[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,111,0,25,[9,41,70,98,134,164,187,211,236,262,293,321,345,373,399,425,451,478,501,528,557,581,604,624,647],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100520642","phase-4-the-optimised-use-of-romozosumab-study-100520642",false,"NCT06059222","The Optimised Use of Romozosumab Study","OPTIMIST","Inclusion Criteria:\n\n* Postmenopausal women (postmenopausal for at least two years)\n* BMD T-score \\\u003C -2.5 at lumbar spine, total hip, or femoral neck\n* Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years.\n\nExclusion Criteria:\n\n* Osteoporosis treatment including hormone replacement therapy within the last 5 years\n* Metabolic bone disease\n* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease\n* Ongoing treatment with glucocorticoids (systemic)\n* Estimated glomerular filtration rate (eGFR) \\\u003C 35 mL\u002Fmin\n* Contraindications for zoledronate according to the Supplementary protection certificates (SPC)\n* Contraindications for romosozumab according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC\n* For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC","FEMALE","50 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","OPTIMIST is a two-year, randomised, active controlled, open-label, multicentre intervention trial. OPTIMIST includes 3 treatment groups each comprising combinations of romosozumab (ROMO) and zoledronate (ZOL) treatment used in standard doses (210 mg monthly (sc) and 5 mg yearly (iv), respectively).\n\nThe study will investigate if it is possible to maximize the effect of romosozumab by giving it in 2 periods of 6 months interrupted by zoledronate for 12 months compared to romosozumab for 12 months uninterrupted followed by zoledronate for 12 months. The investigators will also evaluate if 6 months of romosozumab followed by 18 months of zoledronate is non-inferior to the standard regimen of romosozumab for 12 months followed by zoledronate for 12 months.",[27],"Osteoporosis","RECRUITING","2026-07-01",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2023-10-02",{"date":36,"type":21},"2032-08-31",{"name":38,"class":39},"University of Aarhus","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100645032","can-serum-lumican-level-identify-a-hidden-fragility-phenotype-beyond-bone-mineral-density-in-postmenopausal-women-100645032","NCT07677072","Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women?","LUMINOS","Inclusion Criteria:\n\nInclusion Criteria:\n\n* Female sex\n* Age 45 years or older\n* Postmenopausal status\n* Attendance at the Physical Medicine and Rehabilitation outpatient clinic\n* Undergoing routine bone mineral density (DEXA) assessment and osteoporosis laboratory evaluation\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Premenopausal women\n* Secondary causes of osteoporosis (e.g., malignancy, advanced renal failure, severe liver disease, significant endocrine disorders)\n* Active infection or acute inflammatory disease\n* Major surgery within the previous 6 months\n* Neurological or muscular disorders that may significantly affect muscle function\n* Inability to comply with study procedures and assessments\n* Current treatment with medications that significantly affect bone metabolism, including bisphosphonates, denosumab, teriparatide, or other anti-osteoporotic agents\n* Refusal or inability to provide written informed consent","45 Years",{"count":50,"type":21},98,"OBSERVATIONAL","Osteoporosis is a major cause of morbidity and fragility fractures in postmenopausal women. Bone mineral density (BMD) alone may not fully reflect fracture risk and skeletal fragility. Lumican, an extracellular matrix proteoglycan involved in collagen organization and musculoskeletal tissue homeostasis, has emerged as a potential biomarker for bone health. This prospective observational study aims to investigate the relationship between serum lumican levels, bone mineral density, muscle strength, and clinical fragility indicators in postmenopausal women. Approximately 100 participants will undergo routine osteoporosis assessment including DEXA, laboratory testing, FRAX evaluation, and handgrip strength measurement. The study will evaluate whether serum lumican levels can identify a hidden fragility phenotype beyond conventional bone mineral density measurements.",[27,54,55,56],"Postmenopausal Osteoporosis","Frailty","Fragility Fractures",[58,27,59,60],"Lumican","Fragility","FRAX","2026-06-24",{"date":63,"type":32},"2026-06-30",{"date":65,"type":32},"2026-05-15",{"date":67,"type":21},"2026-12-01",{"name":69,"class":39},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":40},"100644834","functional-muscle-bone-incongruity-index-fkui-a-prospective-observational-study-100644834","NCT07677033","Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study","Functional Muscle-Bone Incongruity Index (FKUI): Combined Evaluation of Handgrip Strength, Total Hip Bone Mineral Density, and Lumbar-Hip Bone Mineral Density Discordance in Adults Undergoing DXA","FKUI","Inclusion Criteria:\n\n* Age 18 years or older\n* Attendance at the Physical Medicine and Rehabilitation outpatient clinic\n* Scheduled to undergo routine bone mineral density assessment by DXA as part of clinical evaluation\n* Ability to perform handgrip strength testing\n* Availability of lumbar spine and total hip bone mineral density measurements suitable for analysis\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing syndrome, malignancy, or other conditions affecting bone metabolism)\n* History of metabolic bone disease\n* Major trauma or fracture within the previous 6 months\n* Upper extremity disorders that may significantly affect handgrip strength measurement (e.g., severe osteoarthritis, neurological disorders, major deformities)\n* DXA measurements that are technically inadequate or unsuitable for analysis\n* Refusal or inability to provide written informed consent","ALL","18 Years",{"count":81,"type":21},200,"The Functional Muscle-Bone Incongruity Index (FKUI) is a novel approach developed to evaluate the relationship between muscle function and bone health. This prospective observational study aims to investigate the clinical applicability of FKUI, which combines handgrip strength, total hip bone mineral density (BMD), and lumbar-hip BMD discordance. Approximately 200 adult participants undergoing routine DXA assessment will be enrolled. The study will examine whether the combined evaluation of muscle function and bone health parameters provides a more comprehensive assessment of musculoskeletal status than individual measures alone.",[27,84,85,86],"Musculoskeletal Health","Sarcopenia","Osteopenia",[88,76,89,90,91],"Functional Muscle-Bone Incongruity Index FKUI","Bone Mineral Density","Hip-Spine Discordance","Handgrip Strength",{"date":63,"type":32},{"date":94,"type":32},"2026-05-01",{"date":96,"type":21},"2027-05-01",{"name":69,"class":39},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":78,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100644098","safety-and-efficacy-clinical-trial-of-the-vessel-x-bone-filling-container-system-100644098","NCT07665424","Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System","The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System","CMT-VX","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Male or female subjects aged ≥40 and ≤95 years.\n2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.\n3. Surgical site within the range of T6 to L5.\n4. Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation.\n5. Subjects willing to comply with the study schedule and all required assessment procedures.\n6. Subjects who are conscious, cognitively intact, and able to provide written informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.\n2. Active or severe systemic infections.\n3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.\n4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.\n5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.\n6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.\n7. Active infection at or adjacent to the surgical site.\n8. Acute spinal instability.\n9. Unwillingness or inability to restrict physical activity or comply with medical instructions.\n10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.","40 Years","95 Years",{"count":109,"type":21},146,[111],"NA","Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.\n\nThe Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.\n\nThis post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:\n\nTri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nTaoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nThe primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.",[27,114],"Osteoporotic Vertebral Compression Fractures",[116,117,118,119,120,121,122,123,124],"Oswestry Disability Index","Visual Analogue Scale","Serious Adverse Device Effect","Last Observation Carry Forward","CMT Vessel-X® Bone Filling Container System","Vesselplasty","Kyphoplasty","Vertebroplasty","Osteoporotic vertebral compression fractures (OVCFs)","2026-06-22",{"date":61,"type":32},{"date":128,"type":32},"2021-04-20",{"date":130,"type":21},"2026-12-31",{"name":132,"class":39},"Juin-Hong Cherng",2,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":40},"100588188","phase-4-effects-of-cycle-therapy-vs-sequential-therapy-with-romosozumab-and-denosumab-in-postmenopausal-osteoporosis-patients-100588188","NCT06938152","Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients","Effects of Cycle Therapy With Romosozumab and Denosumab 2 Years vs 1 Year Romosozumab Followed by 1 Year Denosumab in Postmenopausal Osteoporosis Patients-A Randomized Control Trial","Inclusion Criteria:\n\n* 1\\. Postmenopausal women aged 50-90 years\n* 2\\. BMD T-score ≤ -3.0 at any lumbar vertebra\n* 3\\. Physically and mentally capable of understanding and complying with the study protocol and follow-up\n* 4\\. Signed informed consent\n\nExclusion Criteria:\n\n* 1\\. Previous osteoporosis treatment within the past two years, including Romosozumab, Teriparatide, Denosumab, Alendronate, Ibandronate, Zoledronic Acid, Risedronate, Raloxifene, or Bazedoxifene\n* 2\\. Allergy to Romosozumab or Denosumab\n* 3\\. Secondary osteoporosis\n* 4\\. Autoimmune disease\n* 5\\. Chronic steroid use (e.g., Chronic Obstruction Pulmonary Disease patients)\n* 6\\. Hypercalcemia or hypocalcemia\n* 7\\. Metabolic bone diseases\n* 8\\. Primary or metastatic bone tumors\n* 9\\. Cancer patients (except for in situ carcinoma and non-melanoma skin cancer, unless fully treated and in remission for five years)\n* 10\\. Planned dental procedures (e.g., extractions, implants) within the next year\n* 11\\. History of stent placement, myocardial infarction, stroke, or coronary artery disease\n* 12\\. Renal disease (Creatinine \\> 1.5 mg\u002FdL) or dialysis patients\n* 13\\. Smoking more than one pack per day (except for those who have quit for over ten years)","90 Years",{"count":143,"type":21},70,[24],"This study is a prospective, randomized, controlled clinical trial comparing the efficacy of a 24-month cyclic therapy regimen (6 months of Romosozumab followed by 6 months of Denosumab, repeated for two years) versus a traditional sequential treatment regimen (12 months of Romosozumab followed by 12 months of Denosumab). The goal is to determine which approach yields better therapeutic outcomes and to optimize drug strategies for osteoporosis patients.",[27,147],"Osteoporosis Postmenopausal",[149,150,151,152,153,154],"postmenopausal","Romosozumab","Denosumab","cycle therapy","Bone mineral density","Bone turnover marker","2026-06-21",{"date":157,"type":32},"2026-06-23",{"date":159,"type":32},"2025-04-08",{"date":161,"type":21},"2029-12-31",{"name":163,"class":39},"National Taiwan University Hospital",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":40},"100641583","link-between-ascorbemia-level-and-osteoporosis-100641583","NCT07660484","Link Between ASCorbemia Level and Osteoporosis","ASCO Study: Link Between ASCorbemia Level and Osteoporosis","ASCO","Inclusion Criteria:\n\n* Men aged 50 yars or older ;\n* Postmenopausal women ;\n* Afilliated with a health insurance and system ;\n* Written informed consent obtained.\n* Group 1 : Clincal osteoporotic vertebral fracture confirmed by imaging within the previous month ; Followed in the Rheumatology department for management of vertebral fracture.\n* Group 2 : Densitometric osteoporosis (T-score ≤ -2.5) ; No history of severe osteoporotic fracture ; No history of clinical or morphometric vertebral fracture.\n\nExclusion Criteria:\n\n* Legal protection measure (guardianship, curatorship);\n* inability to provide informed consent ;\n* refusal to participate ;\n* Vertebral fracture related to tumor,\n* infection, trauma or non osteoporotic causes ;\n* asymptomatic vertebral fracture discovered incidentally ;\n* Severe densitometric osteoporosis for group 2 ;\n* Previous severe osteoporotic fracture for group B.",{"count":173,"type":21},40,[111],"This monocentric observational study aims to evaluate the association between plasma vitamin C levels (ascorbemia) and the presence of osteoporotic vertebral fractures in patients with osteoporosis. Forty participants will be enrolled at the Rheumatology",[27,177,178],"Vitamin C Deficiency","Vertebral Fractures","NOT_YET_RECRUITING","2026-06-16",{"date":125,"type":32},{"date":29,"type":21},{"date":184,"type":21},"2028-01-01",{"name":186,"class":39},"Centre Hospitalier Universitaire de Nice",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":40},"100642638","radiographic-cortical-thickness-of-the-humerus-in-detecting-post-stroke-regional-bone-loss-100642638","NCT07651306","Radiographic Cortical Thickness of the Humerus in Detecting Post-Stroke Regional Bone Loss","Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* A documented history of a single unilateral stroke that occurred at least 6 months prior to evaluation.\n* Presence of clinical hemiparesis.\n* Availability of concurrent standard anteroposterior (AP) shoulder radiographs taken within 6 months post-stroke alongside systemic DXA measurements.\n\nExclusion Criteria:\n\n* History of surgical intervention in either shoulder. History of a proximal humerus fracture.\n* Co-existing metabolic bone diseases, such as primary hyperparathyroidism or osteomalacia.\n* History of malignancy.\n* Documented history of corticosteroid use.\n* Imaging artifacts that compromise the accuracy of DXA measurements.\n* History of a secondary stroke.",{"count":194,"type":21},65,"Post-stroke immobilization and reduced weight-bearing frequently lead to significant regional bone mineral density loss and asymmetry, particularly in the paretic upper extremity, which increases fracture risks. While Dual-Energy X-ray Absorptiometry (DXA) is the gold standard for evaluating systemic bone loss, it primarily focuses on axial or lower extremity sites and lacks universal accessibility. Since routine shoulder radiographs offer an opportunistic screening tool to evaluate regional bone quality without additional radiation , this study aims to compare proximal humerus cortical bone thickness between the paretic and non-paretic sides in stroke patients and assess its correlation with systemic DXA values to determine its clinical utility.\n\nThis cross-sectional, observational study involves a retrospective data analysis of patients aged 18 and older who experienced a single unilateral stroke at least 6 months prior and present with clinical hemiparesis. Eligible participants must have concurrent standard anteroposterior shoulder radiographs and DXA measurements available from their routine clinical follow-ups. Patient demographic data, stroke characteristics, Brunnstrom stages, and systemic DXA measurements (femoral neck and lumbar spine T-scores and bone mineral density values) are systematically recorded for analysis.\n\nCortical bone thickness measurements are performed using ImageJ software on standard radiographs at points 10 cm and 12 cm distal to the highest point of the humerus. To ensure reliability, measurements for both the paretic and non-paretic sides are conducted independently by two researchers who are completely blinded to the DXA results. Statistical analyses, including paired t-tests or Wilcoxon tests and Pearson or Spearman correlations, will be used to compare the sides and evaluate the relationship between radiographic cortical thickness and systemic bone density.",[197,198,27],"Hemiparesis After Stroke","Dual Energy X-ray Absorptiometry",[200,201,27,202],"Stroke","Cortical Bone Thickness","Radiography","2026-06-12",{"date":180,"type":32},{"date":206,"type":32},"2026-02-22",{"date":29,"type":21},{"name":209,"class":210},"Istanbul Physical Medicine Rehabilitation Training and Research Hospital","OTHER_GOV",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":218,"sex":78,"minAge":79,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":4},"100642349","clinical-study-on-a-new-diagnostic-strategy-for-osteoporosis-and-sarcopenia-in-chronic-kidney-disease-patients-based-on-mri-ff-100642349","NCT07645794","Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF","A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR","Inclusion Criteria:\n\n1. Age between 18 and 80 years old.\n2. Able to understand and sign the informed consent form.\n3. Able to complete MRI-FF scans of the lumbar spine and thigh.\n4. For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m² for ≥3 months).\n5. For control group: No history of chronic kidney disease and normal renal function.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).\n2. History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.\n3. Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).\n4. Severe lower limb deformity or amputation affecting thigh muscle assessment.\n5. Inability to cooperate with the scan due to cognitive impairment or severe illness.",true,"80 Years",{"count":221,"type":21},868,"This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.",[224,27],"Chronic Kidney Disease",[224,27,85,226,89,227],"MRI-FF","Muscle Fat Fraction","2026-06-09",{"date":203,"type":32},{"date":231,"type":21},"2026-06",{"date":233,"type":21},"2028-12",{"name":235,"class":39},"Capital Medical University",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":78,"minAge":243,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":40},"100643506","robot-assisted-minimally-invasive-treatment-versus-conventional-surgery-for-ffp3-4-fragility-fractures-of-the-pelvis-in-elderly-patients-100643506","NCT07639619","Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery for FFP3-4 Fragility Fractures of the Pelvis in Elderly Patients","Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conventional Surgery in Elderly Patients With FFP3-4 Fragility Fractures of the Pelvis","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Low energy trauma\n* Diagnosis of osteoporosis\n* Diagnosis of FFP3 or FFP4 fragility fractures of the pelvis\n* Injury duration less than 3 weeks\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Severe open injury or skin infection at the surgical site\n* Hemodynamic instability preventing anesthesia or surgery\n* Severe psychiatric disorders or dementia\n* Severe obesity affecting imaging quality\n* Severe systemic diseases preventing surgery\n* Pathological fracture\n* Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy","60 Years",{"count":245,"type":21},88,[111],"This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted minimally invasive treatment versus conventional surgery in elderly patients with FFP3-4 fragility fractures of the pelvis. Eligible patients will be stratified according to FFP classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment. Primary and secondary outcomes include pain relief, early mobilization, functional recovery, perioperative complications, venous thromboembolism events, laboratory parameters, imaging outcomes, and healthcare resource utilization. The study aims to provide evidence for optimizing surgical treatment strategies in elderly patients with unstable pelvic fragility fractures.",[249,27],"Fragility Fractures of the Pelvis (FFP)",[251,252,253],"Fragility Fracture","Robot Assisted Surgery","pelvis",{"date":255,"type":32},"2026-06-10",{"date":257,"type":21},"2026-06-01",{"date":259,"type":21},"2028-12-30",{"name":261,"class":39},"Junbo Liang",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":78,"minAge":270,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":292},"100617973","us-prospective-evaluation-of-epione-device-for-percutaneous-msk-procedures-100617973","NCT07325578","U.S. Prospective Evaluation of EPIONE Device for Percutaneous MSK Procedures","Evaluation of the Epione Robotic System for Image-guided Percutaneous MSK Procedures of the Pelvis and Spine in USA. A Prospective Study on Feasibility, Safety and Accuracy","EPIOS","Inclusion Criteria:\n\n* Patients ≥22 years old,\n* Patients approved for CT- or CBCT-guided MSK procedure in the pelvis or spine (except the cervical area) under general anesthesia,\n* Patients who have signed an IRB-approved informed consent form\n* Patients approved for coverage by their insurance for routine costs involved in this standard of care procedure\n* Inclusion criteria linked to the freehand procedure have been discussed and validated\n\nExclusion Criteria:\n\n* Patients with contraindication to undergo general anesthesia,\n* Patients unable to maintain appropriate breathing control,\n* Patients requiring CT- or CBCT-guided percutaneous procedure on target areas other than those indicated\n* Patients unable to fully understand all relevant aspects of the clinical study necessary for their decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response,\n* Pregnant or breast-feeding women,\n* Patients subject to a legal protection measure,\n* Patients already participating in another conflicting interventional clinical study,\n* Patients for whom the scan field of view cannot contain the anatomy of interest, the overlaying skin surface, skin markers and the whole patient reference.\n* Patients having a coagulation abnormalities or bleeding disorder\n* Patients having an active infection on the day of intervention\n* Patients having a history of previous surgery resulting in an existing hardware precluding percutaneous approach\n* Exclusion criteria linked to the freehand procedure have been discussed and validated","22 Years",{"count":272,"type":21},60,[111],"The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.\n\nThe main question is the determination of the rate of feasible procedures assisted by the Epione device\n\nParticipants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:\n\n* The use of the Epione device to place the introducer(s), instead of freehand placement if they do not participate\n* Additional CT or CBCT scans during the procedure.",[276,27,277],"Bone Tumor","Traumatic Fracture",[279,280,281],"percutaneous procedure","robot assistance","bone procedure","2026-06-03",{"date":284,"type":32},"2026-06-04",{"date":286,"type":32},"2026-04-28",{"date":288,"type":21},"2026-10",{"name":290,"class":291},"Precision IO Group","INDUSTRY",3,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":78,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":40},"100640773","people-with-osteoporosis-can-walk-best-to-reduce-fall-and-fracture-risk-100640773","NCT07621679","People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk","Walk-BEST","Inclusion Criteria:\n\n* men and women 70 years and older\n* able to walk independently with or without a walking aid\n* experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score \\\u003C -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)\n\nExclusion Criteria:\n\n* fracture sustained in the past 12 months\n* unable to walk unsupervised because of active medical or neurocognitive reasons\n* unable to provide informed consent, or cannot communicate in English or French","70 Years",{"count":302,"type":21},28,[111],"The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.",[27],[307,308,309,310,311],"Gait","Wearable","Walking","Falls","Fracture Risk","2026-05-29",{"date":314,"type":32},"2026-06-02",{"date":316,"type":32},"2026-05-07",{"date":318,"type":21},"2027-05",{"name":320,"class":39},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":218,"sex":78,"minAge":106,"maxAge":219,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":292},"100638403","artificial-intelligence-guided-diagnosis-for-high-risk-osteoporosis-populations-a-pragmatic-randomized-clinical-trial-100638403","NCT07620834","Artificial Intelligence-Guided Diagnosis for High-Risk Osteoporosis Populations: A Pragmatic Randomized Clinical Trial","Inclusion Criteria:\n\n* Aged between 40 to 80 years old\n* Identified as high-risk by the Osteoporosis Self-Assessment Tool for Taiwan Postmenopausal Women (OSTAi) \\\u003C-1 or Male Osteoporosis Self-Assessment Tool for Taiwan (MOSTAi) ≦11 based on the individual's age and weight (kg)\n* Had chest x-ray within one year\n\nExclusion Criteria:\n\n* Age \\\u003C 40 years old\n* Age \\>80 years old\n* BMI\\\u003C 18 kg\u002Fm2or \\>30 kg\u002Fm2\n* Pregnant in prior one year\n* Recorded diagnosis of osteoporosis within the past two years\n* History of prior DXA imaging (prior quantification of BMD) within 2 years\n* History of metabolic bone disease",{"count":328,"type":21},1180,[111],"Project Summary\n\nI. Project Objectives\n\nWith the rapid advancement of medical technology, smart medical devices have become one of the key components of modern healthcare. However, integrating these emerging technologies into the national health insurance (NHI) reimbursement system while ensuring their clinical value and economic benefits remains a major challenge worldwide.\n\nThe primary goal of this project is to assist commercialized smart medical device products-those that have passed TFDA review and seek NHI reimbursement-in conducting comprehensive evaluations of their clinical effectiveness and medical economic impact. Through scientific data and standardized impact assessment procedures, the project aims to provide localized evidence to support reimbursement policy decisions and facilitate the market adoption of smart medical technologies. Ultimately, this project seeks to balance therapeutic efficacy and cost control, offering a scientific foundation for NHI decision-making and paving the way for the sustainable development of AI-driven healthcare innovations.\n\nII. Implementation Methods\n\n1. Multi-center Collaborative Network\n\n   This project will be led by Taichung Veterans General Hospital (TCVGH) as the principal site, with collaboration from Kaohsiung Medical University Chung-Ho Memorial Hospital and Changhua Show Chwan Memorial Hospital. This cross-institutional, cross-regional alliance ensures diverse clinical samples, enhances the representativeness of study results, and allows evaluation of AI medical devices across different healthcare systems and environments.\n2. Clinical Trial Design and Implementation for Smart Medical Devices\n\n   The project will design and execute systematic clinical trials for smart medical devices using methodologies such as randomized controlled trials (RCTs), before-and-after studies, pragmatic RCTs (PCTs), cluster RCTs, and stepped-wedge RCTs. These rigorous designs will ensure scientific validity, reproducibility, and practical feasibility in real-world clinical settings.\n3. Health Economic Evaluation\n\n   A key component of this project is the medical economic assessment, conducted by experienced health economists through cost-effectiveness analysis. The evaluation will focus on how smart medical devices reduce healthcare costs, improve diagnostic efficiency, and enhance treatment outcomes, quantifying their economic value within the NHI system. This evidence will guide policy makers in making data-driven reimbursement decisions.\n4. Standardized Impact Assessment Process\n\n   To ensure high-quality research, the project will establish a comprehensive standardized impact assessment framework covering trial design, data collection, statistical analysis, economic evaluation, and ethical review. This standardized approach not only improves the precision of the study but also accelerates the clinical translation of AI medical devices through streamlined application and review processes.\n5. Research Case Study and Clinical Application\n\n   The featured case study in this project is \"VeriOsteo OP® Smart Bone Screening System,\" which targets early osteoporosis screening among adults aged 40 to 80 years in high-risk groups. This study will evaluate the clinical accuracy of AI-based osteoporosis screening and assess its economic contribution to healthcare cost reduction. The findings will directly inform the Ministry of Health and Welfare's NHI Administration in formulating reimbursement standards for AI medical devices.\n6. Data Sharing and Information Security\n\n   Throughout the project, all research data collection, exchange, and sharing will strictly adhere to cybersecurity and privacy regulations. The AI models involved will undergo validation to ensure the reliability and scientific rigor of the results. Furthermore, the project will promote collaboration between manufacturers and healthcare institutions to support the adoption of smart medical technologies.\n7. Final Outcomes and Future Development\n\nThe final deliverables will include a comprehensive evaluation report on the clinical and economic performance of the AI medical device, along with recommendations for NHI reimbursement application. The results will provide a reference model for future AI medical devices entering the reimbursement system and further advance the field of smart healthcare. In the long term, the center aims to expand its research to other disease domains while strengthening data security and ethical oversight to ensure the feasibility and credibility of AI applications in clinical practice.\n\nIII. Expected Outcomes and Future Vision\n\nBy implementing a multi-center collaborative framework, this project aims to promote clinical adoption and economic evaluation of smart medical devices, offering concrete data to support NHI policy-making. Over time, the project is expected to establish a robust evaluation system for AI medical devices, facilitate broader market adoption, and enhance patient outcomes whi",[27],[333,334,335,336],"Software as a Medical Device (SaMD)","Clinical Impact Analysis","Health Economics","Standardization of NHI Reimbursement","2026-05-27",{"date":314,"type":32},{"date":340,"type":32},"2026-03-13",{"date":342,"type":21},"2026-11-12",{"name":344,"class":39},"Taichung Veterans General Hospital",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":18,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":361,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":40},"100604838","phase-4-glp-1r-actions-on-muscle-and-the-skeleton-100604838","NCT07154719","GLP-1R Actions on Muscle and the Skeleton","GRAMS","Inclusion Criteria:\n\n* Subjects will have a BMI between 30kg\u002Fm2\n\n  * 40kg\u002Fm2 (inclusive)\n* Be between 18 and 50 years of age (inclusive).\n* Non-Hispanic Black males and females will be enrolled at PBRC.\n* Rural males and females will be enrolled at MaineHealth.\n* Female subjects will be premenopausal.\n* Females have had their last menstrual period less than 60 days before screening.\n* Females have the absence of menopausal-associated vasomotor symptoms.\n* All subjects must be able to use Lifestyle Toolkit as prescribed for intervention arm.\n\nExclusion Criteria:\n\n\\- Males and females over the age of 50 years of age\n\n* Menopausal females.\n* Subjects on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.\n* Subjects who are on medications that increase or decrease weight status.\n* Subjects having contraindications to tirzepatide in the package insert.\n* Subjects with a history of malignancy other than non-melanoma skin cancer\n* Subjects with known osteoporosis or are on osteoporosis therapies (gonadal hormones or hormone antagonists).\n* Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.\n* Subjects with a clinically significant hematologic abnormality, kidney disease, liver disease, or diabetes.\n* Females of childbearing potential who do not agree to using an effective method of contraception during the study. Medically acceptable methods include oral contraceptive medication, an intrauterine device (IUD), an implantable contraceptive (such as Implanon), or a barrier method (such as condom or diaphragm with spermicide).\n\nInjectable contraceptives such as Depo-Provera are a cause for exclusion in that they can cause bone loss.\n\nAbstinence is acceptable, as is sexual activity exclusively with same sex partners.\n\nFertility Appreciation Based Methods (natural family planning) are also acceptable forms of addressing childbearing potential in all subjects. A urine pregnancy test (UPT) will be performed on all females of childbearing potential at the screening visit, 3 and 6 months.\n\n* Unable to follow Lifestyle Toolkit as prescribed for intervention arm.\n* Patient Health Questionnaire-9 (PHQ-9) Score equal to or greater than 15 (clinical depression).\n* Adults who are unable to consent.\n* Individuals who are not yet adults (infants, children and teenagers).\n* Pregnant females.\n* Incarcerated individuals.\n* Contraindication to MRI - including but not limited to non-removable metallic or electronic implants, claustrophobia or other fear of confinement, inability to tolerate loud scanner noise, body weight greater than 500 pounds.\n* Subjects with a baseline level of 25-OH vitamin D \\\u003C15 ng\u002Fml will be excluded from the trial. The subject's physician will be notified, and the subject will be referred to their primary care physician.\n* Any significant EKG abnormalities that are considered a risk for utilizing weight management therapies.",{"count":353,"type":21},50,[24],"The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.",[357,358,359,27,360],"Musculoskeletal Abnormalities","Obesity","Sarcopenic Obesity","Drug Effect",[362,363,364,365],"GLP-1 agonists","Obesity treatments","Muscleskeletal loss","Tirzepatide","2026-05-26",{"date":312,"type":32},{"date":369,"type":32},"2025-10-09",{"date":96,"type":21},{"name":372,"class":39},"Pennington Biomedical Research Center",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":78,"minAge":106,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":133},"100558441","peripheral-mononuclear-cells-to-screen-monitor-and-stratify-the-population-at-risk-of-osteoporosis-and-fractures-100558441","NCT06551155","Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures","Identification, Monitoring, and Classification of Patients at Risk of Osteoporosis and Fractures Using a Method Based on the Use of Mononuclear Cells From Peripheral Blood","DISCERN","Inclusion Criteria:\n\n* Healthy patients (at risk and undergoing periodic follow-up and\u002For attending outpatient visits for preventive screening)\n* Osteopenic patients with an available DXA\n* Osteoporotic patients (fractured and non-fractured) with an available DXA or, for fractured patients, a DXA prescribed as part of clinical practice\n* Aged ≥ 40 years of both sexes\n* Body Mass Index (BMI) between 18.5 and 29.9\n\nExclusion Criteria:\n\n* Hematopoietic system disorders (hemolytic, aplastic, and neoplastic anemias)\n* Coagulation disorders (hereditary or secondary to other disorders)\n* Infections (including HIV-HBV-HCV positivity)\n* Neoplastic diseases (primary and\u002For secondary tumors)\n* Pregnancy or breastfeeding\n* Alcohol consumption (\\>20 g of alcohol per day currently or in the past)\n* Smoking (\\>10 cigarettes per day, currently or in the past)\n* Diabetes\n* Treatment with therapeutic agents that may interfere with hematopoiesis (corticosteroids, immunosuppressive agents, cytotoxic drugs)",{"count":382,"type":21},120,"Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray Absorptiometry (DXA) is the gold standard for BMD assessment, but for the different OP stages screening and diagnosis, BMD by itself is not an accurate predictor. Thus, OP is often misdiagnosed. Aim of the this study is to improve a tool for OP diagnosis based on the ability of circulating peripheral blood mononuclear cells (PBMCs) to maintain or not their in vitro viability (IRCCS Istituto Ortopedico Rizzoli European patent n.3008470 March 21, 2018) for the measurement of the different OP severity levels, also considering specific gender related differences.",[27,86,385],"Osteoporosis Fracture",[387,388,389],"peripheral blood mononuclear cells","screening","diagnosis","2026-05-25",{"date":392,"type":32},"2026-05-28",{"date":394,"type":32},"2024-08-05",{"date":396,"type":21},"2027-02-20",{"name":398,"class":39},"Istituto Ortopedico Rizzoli",{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":133},"100637120","microrna-and-markers-and-therapeutic-response-to-romosozumab-and-abaloparatide-in-postmenopausal-osteoporosis-100637120","NCT07616401","MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis","MicroRNA and Circulating Markers Predictive of the Therapeutic Response to Romosozumab and Abaloparatide Treatment in Women With Postmenopausal Osteoporosis","ROMIRNA","Inclusion Criteria:\n\n* Female sex\n* Postmenopause\n* Densitometric diagnosis of osteoporosis\n* Normal calcium diet\n* Supplement with cholecalciferol or calcifediol\n\nExclusion Criteria:\n\n* Premenopause\n* Chronic therapy with glucocorticosteroids, or other treatments that may affect bone metabolism\n* Diseases and conditions that may affect bone metabolism",{"count":408,"type":21},42,[111],"Osteoporosis is a systemic skeletal disorder affecting approximately 10% of individuals over 50 years of age. It is characterised by an increased risk of fragility fractures, which constitute a major source of morbidity, mortality, and healthcare burden worldwide.\n\nA range of pharmacological therapies has been approved for osteoporosis, with demonstrated efficacy in reducing fracture risk. These include anabolic agents that stimulate osteoblast-mediated bone formation (teriparatide, abaloparatide), antiresorptive agents that inhibit osteoclast-driven bone resorption (bisphosphonates, denosumab), and dual-action agents such as romosozumab, which, through sclerostin inhibition, simultaneously enhances bone formation and suppresses resorption. In clinical practice, these agents are administered sequentially or in combination to optimise therapeutic outcomes.\n\nThe primary goal of anti-osteoporotic therapy is to reduce the risk of incident and subsequent fractures. In postmenopausal osteoporosis, this objective is closely linked to meaningful gains in bone mineral density (BMD), as measured by dual-energy X-ray absorptiometry (DEXA), with attainment of osteopenic ranges associated with low fracture probability (\\\u003C15% for major osteoporotic fractures and \\\u003C3% for hip fractures, according to FRAX). However, selecting the most effective therapeutic strategy remains challenging, as robust predictors of individual treatment response are lacking. Although bone turnover markers are widely used to monitor treatment effects, their value in predicting clinical outcomes is limited.\n\nMicroRNAs (miRNAs) are small (\\~22 nucleotides), single-stranded, non-coding RNAs that regulate gene expression at the post-transcriptional level through binding to complementary sequences in target mRNAs. Circulating miRNAs are stabilised by association with proteins and extracellular vesicles, making them attractive candidates as biomarkers. Increasing evidence indicates that miRNAs play key roles in osteoblast and osteoclast differentiation, proliferation, and apoptosis, and distinct miRNA expression profiles have been associated with osteoporosis and fragility fractures.\n\nAn emerging area of interest is the interaction between osteoactive therapies and circulating miRNA signatures. To date, available data are largely limited to antiresorptive agents and teriparatide. No studies have yet addressed miRNA expression profiles in patients treated with romosozumab or abaloparatide.\n\nBeyond miRNAs, additional molecular pathways implicated in osteoimmunological crosstalk and ageing are gaining attention as potential biomarkers. Nitric oxide (NO) plays a multifaceted role in bone homeostasis, inhibiting osteoclast activity while promoting osteoblast function. Reduced circulating NO levels have been identified as an independent predictor of osteoporotic fractures in postmenopausal women. Autophagy is increasingly recognised as a critical regulator of bone remodelling, influencing both osteoblastic and osteoclastic activity. Dysregulation of autophagic pathways disrupts bone homeostasis and contributes to bone loss. These processes are tightly controlled by complex molecular networks, including miRNAs, and are closely linked to lysosomal function. In this context, cathepsin K has emerged as a promising therapeutic target in osteoporosis.\n\nThe present study primarily aims to identify circulating microRNAs, whose early treatment-induced changes are predictive of the outcome of the therapy in terms of changes in BMD. Secondary, it aims to identify correlations of the changes in microRNAs serum concentrations with variations in biomarkers of bone metabolism as well as of aging.\n\nThe study enrols women with diagnosis of severe postmenopausal osteoporosis addressed to treatment with romosozumab or with abaloparatide. All women will be assessed at baseline and after 2, 6 and 12 months of treatment.",[27,412],"Menopause",[27,414,415,150,416],"Bone markers","MicroRNA","Abaloparatide","2026-05-23",{"date":257,"type":32},{"date":420,"type":32},"2025-08-31",{"date":422,"type":21},"2029-08-31",{"name":424,"class":39},"Istituto Auxologico Italiano",{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":218,"sex":78,"minAge":106,"maxAge":243,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":437,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":40},"100640983","osteoporosis-and-sarcopenia-prevention-in-middle-aged-population-100640983","NCT07611097","Osteoporosis and Sarcopenia Prevention in Middle-Aged Population","FORTIFY","Inclusion Criteria:\n\n* General Population: Women and men aged 40-60 years, defined as age groups where the rate of injuries were still relatively lower, thus considered as a low to moderate risk cohort for osteoporosis.\n* Risk profile: Targets a low to moderate risk cohort for osteoporosis (e.g., as defined by no prior fragility fracture and questionnaire). This aligns with the study's primary prevention objective.\n* Individuals with well-controlled comorbidities like hypertension, diabetes, or pre-diabetes can be included in the study program. Exercise and healthy nutritional diets can also help treat their existing health conditions.\n\nExclusion Criteria:\n\n* Significant comorbidities: Individuals with existing (e.g., severe or uncontrolled) medical illness, due to risk to aerobic exercise. This includes, but is not limited to, active ischemic heart disease, unstable angina, uncontrolled hypertension, or other conditions as determined by study physicians.\n* High baseline activity: Individuals who have engaged in \\>4 hours intensive sports per week will be excluded. This population is deemed to be at very low risk, thus would likely derive minimal additional benefit from the intervention, and their inclusion could represent inefficient use of finite resources (e.g., DEXA scanning services).",{"count":433,"type":21},8336,[111],"This initiative is designed to yield substantial and multi-level benefits for the Hong Kong community by pioneering a transformative model of preventive healthcare. It represents the largest randomized controlled trial for osteoporosis and sarcopenia prevention in the region, adopting a comprehensive approach to fracture prevention through innovative fitness, lifestyle, and digital strategies.\n\nThe study's primary objective is to evaluate the efficacy of preventing fractures, osteoporosis, and sarcopenia through an incentivized program of fitness and lifestyle modifications in adults aged 40-60. The secondary objectives include: (1) to validate the use of simple, low-cost measures (grip strength and InBody body composition analysis) as reliable proxy indicators for osteoporosis and sarcopenia risk relative to the gold-standard DEXA scan; (2) to develop a formal, standardized clinical protocol for early detection and prevention, including specified DEXA anatomical measurement sites, for use by healthcare professionals in primary and community care settings; (3) to assess changes in exercise behavior, musculoskeletal health, physical function, health literacy, and participant engagement with the digital (AI chatbot) support system; (4) to analyze the cost-effectiveness of the intervention compared to standard care or pharmacological treatment, including an assessment of healthcare utilization and Quality-Adjusted Life Years (QALYs).\n\nAfter baseline screening and consent, participants are randomly assigned to one of two groups (1:1 ratio) with intention-to-treat principles. The Control Group will receive passive, static support. This involves participating in one initial FUN Day, receiving standard exercise videos, using a passive chatbot for data reporting, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving souvenirs at the study start and end. Meanwhile, the Intervention Group will receive active, dynamic support designed to build and reinforce healthy habits. This involves participating in the initial FUN Day, a reinforcement FUN Day at 2 months, nine mandatory structured exercise touchpoints, using an active chatbot with reminders, feedback, and gamification, undergoing start and end DEXA scans (which require a co-payment), completing a 3-month assessment, and receiving ongoing incentives and souvenirs at multiple points. Therefore, researchers will compare between the control and intervention groups to see if intervention can prevent osteoporosis and sarcopenia at a population level.\n\nAll participants will undergo a series of assessments at specific timepoints. This includes two DEXA scans (at the study start and in the fourth year, requiring a participant co-payment), InBody composition analysis, and physical health assessments (e.g., grip strength, balance, cardiovascular fitness). These assessments will be performed at baseline (during the first FUN Day), 3 months, 12 months, 24 months, and 36 months. A long-term follow-up will continue for up to 10 years to monitor adverse health events such as falls and fractures. Participants will also complete questionnaires via an AI chatbot at baseline, 3 months, and annually during follow-up. The collected data will encompass health literacy (e.g., osteoporosis\u002Fsarcopenia knowledge scores), digital engagement (e.g., chatbot responsiveness), and economic outcomes (e.g., incremental cost per Quality-Adjusted Life Year \\[QALY\\] gained). Data analysis will employ appropriate statistical methods to compare outcomes between the control and intervention groups across all assessments and timepoints.",[27,85],[438,439,440,441,442,443],"Randomized Controlled Trial","Middle-Aged Population","Osteoporosis Prevention","Sarcopenia Prevention","AI Chatbot","DEXA Alternative","2026-05-20",{"date":392,"type":32},{"date":257,"type":21},{"date":448,"type":21},"2036-05-31",{"name":450,"class":39},"The University of Hong Kong",{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":218,"sex":17,"minAge":459,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":133},"100536894","clinical-validation-of-bbct-hip-100536894","NCT06270758","Clinical Validation of BBCT-hip","Clinical Validation of BBCT-hip Methodology for Femur Fracture Risk Prediction","ValidaBBCT-hip","Inclusion Criteria:\n\n* caucasic post-menopausal women resident in Emilia-Romagna\n* menopause (\\>= 45 years)\n\nExclusion Criteria:\n\n* tumours\n* not free living\n* Chronic diseases with severe organ failure \u002F endocrine diseases of parathyroid, thyroid, adrenal gland \u002F intestinal malabsorption, osteomalacia \u002F Paget bone \u002F rheumatoid arthritis. Neurodegenerative diseases\n* Long-term continuous therapy (\\>3 months) with corticosteroids and proton pump inhibitors or aromatase inhibitors\n* Previous femur fractures\n* Presence of hip\u002Fknee prosthesis\n\nonly for the fracturegroup:\n\n* presence of fixation devices after the fracture\n* femur fracture due to high energy trauma","65 Years","85 Years",{"count":462,"type":21},300,"The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study.",[27],[466,467,468,469,470],"hip fracture","fracture prediction","finite element","in silico","osteoporotic fracture",{"date":472,"type":32},"2026-05-22",{"date":474,"type":32},"2023-11-07",{"date":476,"type":21},"2030-11-06",{"name":398,"class":39},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":218,"sex":78,"minAge":243,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":40},"100459773","mode-of-exercise-and-bone-biomarkers-in-older-veterans-100459773","NCT05266976","Mode of Exercise and Bone Biomarkers in Older Veterans","Anabolic Versus Catabolic Skeletal Effects of Endurance or Resistance Exercise in Older Veterans","MOVE","Inclusion Criteria:\n\n* Healthy older (60+ y) Veteran women and men in the Denver Metro Area\n* Normally active (e.g., recreational cycling or walking exercise)\n\nExclusion Criteria:\n\n* Impaired renal function, defined as an eGRF of \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Hepatobiliary disease, defined as liver function tests (AST, ALT) \\>1.5 times the upper limit of normal\n* Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \\\u003C0.5 or \\>5.0 mU\u002FL\n* Serum Ca \\\u003C8.5 or \\>10.3 mg\u002FdL\n* Serum 25(OH)D \\\u003C20 ng\u002FmL\n* Uncontrolled hypertension, defined as resting systolic blood pressure (BP) \\>150 mmHg or diastolic BP \\>90 mmHg;\n* History of type 1 or type 2 diabetes\n* Cardiovascular disease, defined as subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT). Volunteers who have a positive GXT can be re-considered after follow-up evaluation, which must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist\n* Anemia, defined as a serum hemoglobin \\\u003C12.1 g\u002FdL for women and \\\u003C14.3 g\u002FdL for men\n* Fracture in the past 6 months\n* Current diagnosis or symptoms of COVID-19\n\nIn the event of abnormal BP, live function, TSH, 25(OH)D, or hemoglobin values, volunteers can be reassessed, including after appropriate follow-up evaluation and treatment by a primary care provider. Those who have experienced symptoms of COVID-19 or have been formally diagnosed will be allowed to participate once symptoms have resolved and they are approved to return to exercise by their primary care provider.",{"count":382,"type":21},[111],"Adults are often encouraged to exercise to maintain or improve bone health. However, there is evidence that exercise does not always lead to increases in bone mass, and exercise could lead to bone loss under certain conditions. Endurance exercise can increase bone resorption following an exercise bout, which may explain why bone does not always favorably adapt to exercise, but it is unclear if this also happens with resistance exercise. Further, it is not known how exercise training influences blood markers of bone resorption for either endurance or resistance exercise. The purpose of this study is to determine 1) if resistance exercise causes a similar increase in bone resorption as endurance exercise; and 2) if exercise training influences the increase in bone resorption following exercise for both endurance and resistance exercise.",[490,491,27],"Aging","Musculoskeletal Diseases","2026-05-19",{"date":472,"type":32},{"date":495,"type":32},"2022-07-06",{"date":497,"type":21},"2027-06-30",{"name":499,"class":500},"VA Office of Research and Development","FED",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":78,"minAge":4,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":524,"leadSponsor":526,"locationsCount":40},"100638596","grace-ii-general-retrospective-analysis-of-commercial-experience-with-agn1-loep-100638596","NCT07594639","GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)","Retrospective Study of OSSURE LOEP in Osteopenic and Osteoporotic Subjects in the Commercial European Market","Inclusion Criteria:\n\n* Subject has previously received AGN1 LOEP treatment in the proximal femur after September 2019 and before January 2026.\n* Subject can give written informed consent to allow for data collection. Obtaining informed consent is not required for deceased subjects.\n\nExclusion Criteria:\n\n-The subject's AGN1 LOEP treatment was previously performed as part of an AgNovos prior protocoled clinical study.",{"count":509,"type":21},305,"The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated between September 2019 and January 2026. Subjects treated as part of an AgNovos prior protocoled study are excluded. Investigators are asked to reach out to all subjects that were previously treated with the AGN1 LOEP Kit in the proximal femur. Subject informed consent is obtained before a subject is enrolled into the study. Subjects treated but not enrolled are documented in a log with the reason why a subject did not participate. This log is kept on site. Enrolled subjects will be contacted per telephone to collect information about any fractures sustained post-AGN1 LOEP treatment.",[27],[153,513,514,515,516,517,518,519,520,521],"Femoral strength","Hip fracture","Local osteo-enhancement procedure","LOEP","Proximal femur","Osteogenesis Imperfecta","OI","Hypophosphatasia","HPP",{"date":492,"type":32},{"date":257,"type":21},{"date":525,"type":21},"2026-09-30",{"name":527,"class":291},"AgNovos Healthcare, LLC",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":78,"minAge":459,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":540,"conditions":541,"keywords":544,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":40},"100639066","phase-2-tcm-formula-vs-hmb-in-pre-frail-elders-muscle-strength-and-bone-status-100639066","NCT07597850","TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status","Effects of Traditional Chinese Medicine (TCM) Formula vs. HMB on Muscle Strength and Bone Status in Pre-Frail Elders: A Comparative Study","TCM-HMB-PF","Inclusion Criteria:\n\n* Male or female participants aged 65 years or older at the time of screening.\n* Body Mass Index less than 30 kilograms per square meter.\n* Identified as pre-frail according to the Fried frailty phenotype, meeting 1 to 2 of the following 5 criteria: 1) Hand grip strength below specific thresholds based on gender and Body Mass Index. For males, Body Mass Index 24 or less is 29 kilograms or less, Body Mass Index 24.1 to 28 is 30 kilograms or less, Body Mass Index greater than 28 is 32 kilograms or less. For females, Body Mass Index 23 or less is 17 kilograms or less, Body Mass Index 23.1 to 26 is 17.3 kilograms or less, Body Mass Index 26.1 to 29 is 18 kilograms or less, Body Mass Index greater than 29 is 21 kilograms or less. 2) Slow walking speed. For a 4-meter distance, walking time of 7 seconds or more for males 173 centimeters or shorter, or 6 seconds or more for males taller than 173 centimeters. For females 159 centimeters or shorter, 7 seconds or more, or 6 seconds or more for females taller than 159 centimeters. 3) Self-reported exhaustion. Answering 3 days or more per week to either feeling that everything was an effort or could not get going in the past week. 4) Unintentional weight loss. Loss of 3 kilograms or more or more than 5 percent of body weight in the past year. 5) Low physical activity. Weekly energy expenditure less than 383 kilocalories for males or less than 270 kilocalories for females.\n* Ability to safely complete a 6-meter walk test in a single attempt without assistance or using only simple aids such as a cane.\n* Clinically stable condition allowing for follow-up visits every 4 weeks and participation in all study-related assessments.\n* Willingness to provide existing test data from within 90 days prior to randomization, including Bone Mineral Density by DXA and serum biochemistry or urinalysis results.\n* Sufficient cognitive function to understand the study and sign the informed consent form, or with the assistance of a legal representative.\n* Willingness to maintain existing diet and exercise habits during the study and not start high-intensity exercise programs or large amounts of nutritional supplements.\n\nExclusion Criteria:\n\n* Major acute illness such as acute myocardial infarction, pneumonia, or acute stroke within 2 weeks prior to screening.\n* Major organ dysfunction, including renal function with estimated glomerular filtration rate less than 45 milliliters per minute per 1.73 square meters within 1 month prior to screening, liver function with AST or ALT greater than 3 times the upper limit of normal within 1 month prior to screening, NYHA Class III or IV heart failure, or severe COPD requiring long-term oxygen therapy.\n* Unplanned hospitalization within 1 month prior to screening, or major surgery with incomplete functional recovery within 3 months prior to screening.\n* Current malignant tumor under treatment, or less than 12 months since the completion of cancer treatment.\n* Use of supplements containing the same ingredients as the study interventions, or products that may affect the primary endpoint including HMB, creatine, branched-chain amino acids, or high-dose protein powder within 4 weeks prior to screening.\n* Known significant clinical allergy or hypersensitivity to any components of the study formula or HMB nutritional supplement.\n* Moderate to severe dementia, severe depression, or other psychiatric disorders resulting in inability to cooperate without a legal representative.\n* Participation in other interventional clinical trials involving drugs, biologics, or nutritional supplements within 3 months prior to screening.\n* New initiation or dose adjustment of medications affecting muscle or bone metabolism within 3 months prior to screening, including systemic glucocorticoids, anabolic steroids, testosterone, or growth hormones.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study due to safety or compliance concerns.",{"count":537,"type":21},90,[539],"PHASE2","The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.",[542,85,543,27,490],"Pre-Frailty","Muscle Atrophy or Weakness",[545,546,547,91,548,549,438],"Traditional Chinese Medicine","HMB (Hydroxy-beta-methylbutyrate)","Muscle Strength","Body Composition","Elderly Health","2026-05-13",{"date":492,"type":32},{"date":553,"type":32},"2026-04-02",{"date":130,"type":21},{"name":556,"class":39},"Tri-Service General Hospital",{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":40},"100640591","post-osteoporotic-fracture-exercise-program-100640591","NCT07595991","Post-osteoporotic Fracture Exercise Program","Community Osteoporosis Exercise Class for People Post Fracture","Inclusion Criteria:\n\n* Diagnosed with osteoporosis.\n* History of low trauma fracture within the past year\n* Cleared for physical activity using the get active questionnaire, 100 bpm resting heart rate or less, 160 mm Hg diastolic blood pressure or less\n* Able to understand and provide informed consent.\n* Residing within the study's geographic area (e.g., London, Ontario).\n\nExclusion Criteria:\n\n* Individuals who do not understand the English language\n* Medical conditions contraindicating participation in exercise (e.g., uncontrolled cardiovascular disease, severe respiratory illness).\n* Cognitive impairments that prevent informed consent or participation.\n* Recent major surgeries or medical events limiting physical activity.\n* Participation in conflicting clinical trials or rehabilitation programs.\n* Residents outside the designated study area.",{"count":565,"type":21},100,[111],"Those with osteoporosis often have weaker bones and this leads to higher chances of fractures. Therefore, the investigators want to evaluate the feasibility and safety of group exercise classes specifically designed for individuals with osteoporosis who had an osteoporotic fracture. By focusing on this high-risk population, the investigators want to see whether such exercise interventions can be an option for improving bone health, reducing the risk of future fractures, and enhancing physical function without compromising safety.",[27,569],"Osteoporotic Fracture",[27,571,572],"Exercise Intervention","Osteoporotic fracture","2026-05-12",{"date":492,"type":32},{"date":576,"type":21},"2026-05",{"date":578,"type":21},"2028-02",{"name":580,"class":39},"Western University, Canada",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":218,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":40},"100595265","resting-state-imaging-and-osteoporosis-100595265","NCT07030205","Resting-state Imaging and OSteoporosiS","ROSS","Inclusion Criteria (patients):\n\n* Women aged 50 or over, with postmenopausal osteoporosis, fractured or not, diagnosed by their rheumatologist,\n* Able to give informed consent to participate in the research,\n* Affiliation with the French Social Security.\n\nInclusion Criteria (healthy volunteers):\n\n* Women aged 50 or over,\n* Bone densitometry performed as part of the protocol, not suggestive of osteoporosis and validated by investigators,\n* Matched to patients by age, menopausal status, socio-educational level and manual laterality,\n* Able to give informed consent to participate in the research,\n* Affiliation with the French Social Security.\n* Registration or acceptance of registration in the national register of volunteers participating in Research.\n\nExclusion Criteria (patient and healthy volunteers):\n\n* Presence of pacemaker,\n* Presence of medical devices (implants or prostheses),\n* Incompatibility of the patient with the safety criteria of the medical imaging center for carrying out magnetic resonance experiments at 3 Tesla,\n* Contraindications to the realization of MRI without injection such as claustrophobia proven, hearing aid, pacemaker wearers, wearing a brain clip,\n* Refusal to be informed in the event of the accidental discovery of an anomaly during the resting state functional magnetic resonance imaging,\n* Woman under legal protection or deprived of liberty,\n* Refusal to participation",{"count":589,"type":21},66,[111],"This study will be conducted in 20 postmenopausal healthy volunteers, 20 postmenopausal osteoporotic patients with fracture and 20 postmenopausal osteoporotic women without fracture, in order to compare functional connectivity between brain areas. Participants will complete different questionnaires and tests assessing cognition, quality of life, sleep, physical activity, pain, anxiety and depression. A biological sample will be performed in order to evaluate different markers of bone remodeling. A Resting-state functional magnetic resonance imaging (rs-fMRI) will be realized in order to establish functional connectivity between brain regions.",[27],[27,594,595],"Resting state fMRI (rs-fMRI)","Cognition","2026-05-11",{"date":550,"type":32},{"date":599,"type":32},"2025-09-03",{"date":601,"type":21},"2027-12-01",{"name":603,"class":39},"University Hospital, Clermont-Ferrand",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":78,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":623},"100595042","the-osteoporotic-fracture-classification-based-scoring-system-for-treatment-decision-in-thoracolumbar-osteoporotic-fractures-100595042","NCT07027306","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures","The Osteoporotic Fracture Classification-based Scoring System for Treatment Decision in Thoracolumbar Osteoporotic Fractures: An International Multicenter Prospective Study","Inclusion Criteria:\n\n* Postmenopausal women ≥ 50 years old or men \\> 60 years old\n\n  o Menopause refers to amenorrhea for 1 complete year.\n* Radiologically confirmed new diagnosis of symptomatic, single or multilevel TL (from T1 to L5) fractures, ie, the index fracture(s).\n\n  * In case of a multilevel fracture, the fracture must be contiguous.\n  * The index fracture is confirmed by MRI as an insufficiency (or fragility) fracture or is confirmed by CT or MRI as traumatic fracture (low-energy trauma)\n* The index fracture(s) is a result of primary osteoporosis. Diagnosis of primary osteoporosis is based on any of the followings in the absence of causes for secondary osteoporosis (such as long-term use of steroids, rheumatoid arthritis, type 1 diabetes mellitus \\[DM\\], and other metabolic bone disorders \\[eg, rickets\u002Fosteomalacia, Paget's disease, osteogenesis imperfecta, and primary hyperparathyroidism\\]) \\[13-15\\]:\n\n  * A T-score ≤ -2.5 in the lumbar spine, femoral neck, total hip, or 1\u002F3 radius\n  * Presence of fragility fracture (either a previous fragility fracture or the index fracture is a fragility fracture). Fragility fractures are fractures due to no or low-energy trauma, eg, slips, trips, or falls from less than double the body height, and heavy lifting.\n* The index osteoporotic TL fracture being classified based on the OF Classification from OF 1 to OF 5:\n\n  * OF 1: No deformation (vertebral body edema on MRI using short tau inversion recovery \\[STIR\\] sequence)\n  * OF 2: Deformation of one endplate\n  * OF 3: Deformation of one endplate with distinct posterior wall involvement\n  * OF 4: Deformation of both endplates with\u002Fwithout posterior wall involvement\n  * OF 5: Injuries with anterior or posterior tension band failure\n* Ability to provide informed consent according to the EC\u002FIRB defined and approved procedures\n\nExclusion Criteria:\n\n* Patients with spinal tumors\n* Patients with concomitant cervical fractures\n* Patients showing any signs of spinal infections\n* Patients with fractures due to high-energy or high-impact trauma, eg, a fall from double the body height or higher, motor vehicle accident with \\> 100 km\u002Fh in cars with airbags, or motor vehicle accident \\> 50 km\u002Fh without airbags, polytrauma\n* Patients with concomitant fracture in the pelvis, upper extremities, and\u002For lower extremities which could affect the main study outcomes (specifically, patient mobility and pain)\n* Patients for whom no FUs are possible\n* Previous instrumented surgery in the affected spine levels\n* Patients with single-level fracture or contiguous multilevel fracture adjacent to previous instrumented surgery\n* Patients who are mentally impaired and therefore not able to adhere to the study procedures and data collection\n* Patients who are bedridden before the index fracture\n* Recent history of substance abuse (ie, recreational drugs and alcohol) that would preclude reliable assessments\n* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study",{"count":612,"type":21},648,"This is an international multicenter prospective observational study. Patients with radiologically confirmed, symptomatic, single- or multilevel contiguous TL (from T1 to L5) fractures as a result of primary osteoporosis will be recruited from participating clinics\u002Fhospitals (ie, study sites). Fractures included are insufficiency fractures (confirmed by magnetic resonance imaging \\[MRI\\]) and traumatic fractures (low-energy trauma, confirmed by computed tomography \\[CT\\] or MRI).",[615,27],"Osteoporotic Fractures",{"date":550,"type":32},{"date":618,"type":32},"2026-03-19",{"date":620,"type":21},"2030-12-01",{"name":622,"class":39},"AO Foundation, AO Spine",15,{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":459,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":634,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":589},"100423628","restore---study-of-agn1-loep-to-prevent-secondary-hip-fractures-100423628","NCT04796350","RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures","Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures","Inclusion Criteria:\n\n1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age.\n2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.\n3. Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review):\n\n   * Documented falls assessment indicating subject is at moderate or high risk of falls\n   * Falls history (2 or more falls in the previous 12 months)\n   * History of vertigo, dizziness, or postural hypotension\n   * Documented T-score \\\u003C -2.5 at the hip\n   * Taking more than 3 daily prescription medications\n   * Visual impairment as confirmed by one of the following:\n\n     * Subject reports difficulty seeing\n     * Lack of depth perception or vision loss in one eye\n     * Macular degeneration\n     * Cataracts\n   * Prior non-hip fragility fracture\n   * Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium\n   * Parkinson's disease stage 3 or 4\n   * 10-year hip fracture probability \\>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country\n4. Subject is expected to be ambulatory after the hip fracture repair procedure. \"Ambulatory\" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices.\n5. Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements.\n6. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.\n\nExclusion Criteria:\n\n1. Criterion omitted\n2. Criterion omitted\n3. Subject is currently enrolled in another interventional clinical study affecting the target hip.\n4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.\n5. Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery.\n6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment.\n7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side.\n8. Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and\u002For treated for atypical femoral fractures.\n9. Criterion omitted\n10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).\n11. Criterion omitted\n12. Subject has active cancer\n13. Criterion omitted\n14. Criterion omitted\n15. Criterion omitted\n16. Criterion omitted\n17. Criterion omitted\n18. Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \\\u003C 15 mL\u002Fmin.\n19. Criterion omitted\n20. Criterion omitted\n21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.\n22. Subject has known allergies to calcium-based bone void fillers.\n23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE orthopedic surgical procedure such as a total hip arthroplasty in her current medical, physiological condition.\n24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.","91 Years",{"count":633,"type":21},2400,[111],"A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.",[251,637,27],"Hip Fractures",[27,639,251,516,640,515],"Hip Fracture","RESTORE",{"date":550,"type":32},{"date":643,"type":32},"2021-04-24",{"date":645,"type":21},"2029-04-01",{"name":527,"class":291},{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":78,"minAge":79,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":656,"conditions":657,"keywords":658,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":40},"100598156","self-questionnaire-in-osteoporosis-100598156","NCT07067827","Self-questionnaire in Osteoporosis","Clinical Validation of a Self-questionnaire in Adults With Osteoporosis","Inclusion Criteria:\n\n* Adult over 18\n* Followed by the rheumatology or endocrinology clinics at the CHUL (CHU de Quebec-Universite Laval)\n* Suffer from osteoporosis\n* Have internet access\n\nExclusion Criteria:\n\n* Unfit, unable to consent, unable to answer a questionnaire, unknown family history (e.g. adopted person)",{"count":655,"type":21},58,"Osteoporosis is a multifactorial disease in which genetic predispositions play a key role in its development. A better understanding of family history and clinical manifestations among first- and second-degree relatives can help improve early detection and personalized care for at-risk patients. To this end, we will test a self-administered questionnaire previously developed by our research team. This questionnaire includes the main manifestations associated with rare genetic bone diseases such as osteogenesis imperfecta, hypophosphatasia, and osteopetrosis.",[27],[659,660,661,662],"osteoporosis","self-administered questionnaire","family history","rare genetic bone diseases","2026-05-05",{"date":665,"type":32},"2026-05-08",{"date":667,"type":32},"2026-04-01",{"date":669,"type":21},"2027-12-31",{"name":671,"class":39},"CHU de Quebec-Universite Laval"]