[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporosis-postmenopausal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporosis-postmenopausal":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,49,74,94,122,153,180,202,226,245,267,289,312,339,379],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100588188","phase-4-effects-of-cycle-therapy-vs-sequential-therapy-with-romosozumab-and-denosumab-in-postmenopausal-osteoporosis-patients-100588188",false,"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)","FEMALE","50 Years","90 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.",[27,28],"Osteoporosis","Osteoporosis Postmenopausal",[30,31,32,33,34,35],"postmenopausal","Romosozumab","Denosumab","cycle therapy","Bone mineral density","Bone turnover marker","RECRUITING","2026-06-21",{"date":39,"type":40},"2026-06-23","ACTUAL",{"date":42,"type":40},"2025-04-08",{"date":44,"type":21},"2029-12-31",{"name":46,"class":47},"National Taiwan University Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100558981","phase-4-combined-anabolic-therapy-100558981","NCT06558188","Combined Anabolic Therapy","Combined Anabolic Therapy Study","CAT","Inclusion Criteria:\n\n* women aged 45+\n* postmenopausal\n* osteoporotic with high risk of fracture\n\nExclusion Criteria:\n\n* no significant previous use of bone health modifying treatments\n* known congenital or acquired bone disease other than osteoporosis\n* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease\n* abnormal calcium or parathyroid hormone level\n* serum vitamin D \\\u003C20 ng\u002FdL\n* anemia (hematocrit \\\u003C32%)\n* history of malignancy (except non-melanoma skin carcinoma)\n* excessive alcohol use or substance abuse\n* known contraindications to romosozumab or teriparatide",true,"45 Years",{"count":60,"type":21},50,[24],"In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.",[64,27],"Osteoporosis, Postmenopausal","2026-04-14",{"date":67,"type":40},"2026-04-17",{"date":69,"type":40},"2025-02-03",{"date":71,"type":21},"2028-04-01",{"name":73,"class":47},"Massachusetts General Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":48},"100492194","mechanisms-of-anabolic-osteoporosis-therapy-100492194","NCT05688969","Mechanisms of Anabolic Osteoporosis Therapy","Inclusion Criteria:\n\nAll postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be offered enrollment. The FDA approved indication for romosozumab is: \"the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.\" Volunteers must be:\n\n1. Female aged \\> 45 years\n2. Postmenopausal by either of the following criteria:\n\n   1. \\> 36 since last spontaneous menses\n   2. \\> 36 months since hysterectomy, plus serum FSH \\> 40 units \u002F liter if \\\u003C 60 years\n\nExclusion Criteria:\n\n* renal disease (stage 4 CKD)\n* elevated blood PTH (intact PTH \\> 77 pg\u002Fml).\n* serum 25-OH vitamin D \\\u003C 20 ng\u002Fml\n* major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.\n* excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.\n* known congenital or acquired bone disease other than osteoporosis.\n* exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.\n* exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.\n* any prior exposure to romosozumab.",{"count":81,"type":21},16,[83],"NA","The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.",[64],"2025-12-17",{"date":88,"type":40},"2025-12-18",{"date":90,"type":40},"2023-06-14",{"date":92,"type":21},"2028-12",{"name":73,"class":47},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":48},"100604358","telerehabilitation-versus-traditional-balance-training-in-women-with-osteoporosis-100604358","NCT07148479","Telerehabilitation Versus Traditional Balance Training in Women With Osteoporosis.","Comparison of Telerehabilitation and Traditional Balance Training in Post Menopausal Women With Osteoporosis.","Inclusion Criteria:\n\n* • Women diagnosed with osteopenia and osteoporosis at hip and lumbar spine through DEXA\n\n  * Age 50-70 years\n  * Have mobile phones and can communicate in video call\n  * Have Balance score (21-44) on berg balance scale\n  * A caregiver must be available to assist the participant during Tele sessions.\n\nExclusion Criteria:\n\n* • Women with severe mobility impairments.\n\n  * Women with cognitive conditions affecting participation.\n  * Women with lower limb joint injury or surgery","70 Years",{"count":103,"type":21},60,[83],"Osteoporosis is a silent disease that leads to fractures, postural deformities, and impaired balance, especially in postmenopausal women. In Pakistan, prevalence is high, with 39% of women reported as severely osteoporotic. Postmenopausal women with osteoporosis and balance issues face increased fall risk due to poor bone density, weakened muscles especially in the lower limb band altered posture .Balance and strength training reduce fall risk, but access to in-person rehabilitation is limited. Telerehabilitation provides remote delivery of structured exercise programs and has shown positive outcomes in balance and bone health. Few studies, however, have compared telerehabilitation with conventional training across all balance domains. The goal of this randomized controlled trial is to compare the effect of Telerehabilitation and Traditional Balance Training in Post Menopausal Women with osteoporosis. Participants will be randomly assigned to one of the two groups, and both will receive an identical standardized balance training program . The results of this clinical trial will help evaluate how telerehabilitation can improve the balance of postmenopausal women with osteoporosis and improve health outcomes.",[28],[108,109,27,110,111],"Telerehabilitation","Balance","Posmenopausal","Virtual exercise","NOT_YET_RECRUITING","2025-11-28",{"date":115,"type":40},"2025-12-01",{"date":117,"type":21},"2026-01",{"date":119,"type":21},"2026-07",{"name":121,"class":47},"Riphah International University",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":57,"sex":16,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":48},"100612431","effect-of-mechanical-loading-and-bone-loss-on-motor-neuron-activity-h-reflex-relationship-100612431","NCT07253493","Effect of Mechanical Loading and Bone Loss on Motor Neuron Activity-H-Reflex Relationship","The Effect of Mechanical Loading and Bone Loss on the Relationship Between Motor Neuron Pool Activity and H-Reflex Amplitude","Inclusion Criteria:\n\n* Being in the postmenopausal period\n* For the osteoporosis group: having femoral osteoporosis (femoral neck or total femur T-score ≤ -2.5)\n* For the control group: having no osteoporosis or osteopenia (femoral neck and total femur T-scores \\> -1, and L1-L4 and L2-L4 T-scores \\> -1)\n* Being a volunteer\n\nExclusion Criteria:\n\n* Receiving osteoporosis treatment\n* Having a peripheral or central nervous system disorder (e.g., stroke, polyneuropathy, radiculopathy, entrapment neuropathy, etc.)\n* Having acquired or hereditary muscle diseases (myopathies)\n* Having active painful lower extremity pathologies (e.g., osteoarthritis, inflammatory joint diseases, etc.)\n* Having cardiac arrhythmias\n* Having a history of other metabolic bone diseases\n* Having skin lesions at the electrode placement sites on the lower extremities\n* Being older than 65 years","18 Years","65 Years",{"count":132,"type":21},24,[83],"Weight-bearing exercises (e.g., running, jumping, whole-body vibration) are widely practiced due to their beneficial effects on bone development and their role in the prevention and treatment of osteoporosis. However, the underlying neuroregulatory mechanisms responsible for these positive effects have not yet been fully understood. Two main neuromodulatory mechanisms have been proposed in the literature: (i) spinal reflexes originating from muscle spindles (stretch reflex, tonic vibration reflex), and (ii) the bone myoregulation reflex (BMR) based on load-sensitive osteocytes.\n\nIt is well established that increased voluntary contraction and the associated rise in background EMG activity, that is, motor neuron pool activity, enhance muscle spindle-based reflex responses (such as the H-reflex and tendon reflex). In contrast, it has been demonstrated that the H-reflex is suppressed during bone-loading activities such as single-leg stance, jumping, or whole-body vibration.\n\nThis study is based on two hypotheses:\n\n* As mechanical loading increases, Ia inhibitory effects intensify, leading to greater H-reflex suppression.\n* During whole-body vibration, the H-reflex is suppressed due to Ia inhibition.\n\nIf this inhibition originates from load-sensitive receptors-osteocytes-and thus from the BMR, then in osteoporosis, where osteocyte number and function are reduced, H-reflex suppression will be diminished.\n\nThe aim of this research is to test these hypotheses. Confirmation of these assumptions would suggest that reflex control during weight-bearing exercise occurs predominantly through osteocyte-mediated BMR mechanisms rather than muscle spindle-based mechanisms such as the stretch or tonic vibration reflex.",[28],[137,138,139,140,141,142,143],"H-reflex","osteoporosis","whole-body vibration","mechanical load","osteocyte","bone myoregulation reflex","background EMG activity","2025-11-19",{"date":113,"type":40},{"date":147,"type":40},"2025-11-18",{"date":149,"type":21},"2026-04",{"name":151,"class":152},"Istanbul Physical Medicine Rehabilitation Training and Research Hospital","OTHER_GOV",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":160,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100611594","bone-turnover-markers-and-treatment-efficacy-in-postmenopausal-osteoporosis-100611594","NCT07242612","Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis","Determination of Selective Bone Turnover Markers and Their Association With Treatment Efficacy in Primary Postmenopausal Osteoporotic Women: A Randomized Control Trial","Inclusion Criteria:\n\n* Postmenopausal women (at least one year since last menstrual cycle).\n* Age greater than 50 years.\n* Diagnosis of primary osteoporosis.\n* Currently not on any anti-osteoporosis medications.\n* Not taking Calcium or Vitamin D supplements.\n* Volunteer to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Women with multiple vertebral fractures or severe lumbar degenerative changes.\n* Use of hormone\u002Festrogen therapy, calcitonin, oral bisphosphonates, IV ibandronate, IV Zoledronic acid, denosumab, or teriparatide within the past 18 months.\n* Use of corticosteroids (short or long-term).\n* History of hyperthyroidism, hypothyroidism, liver disease, kidney disease, or tumors.\n* Presence of secondary causes of osteoporosis (e.g., eating disorders, celiac disease, diabetes, hematologic disorders).","ALL",{"count":162,"type":21},40,[83],"This study investigates the use of blood tests known as Bone Turnover Markers (BTMs) to quickly monitor the effectiveness of osteoporosis treatment in postmenopausal women. Osteoporosis, which weakens bones and increases fracture risk, is typically monitored using a DEXA scan to measure bone density (BMD), but this method changes slowly. BTMs may show a response to medication within just 3 to 6 months. In this randomized controlled trial, 40 postmenopausal women with osteoporosis will be assigned to receive either antiresorptive drugs (which slow bone loss) or anabolic drugs (which build new bone), along with calcium and vitamin D. The study will compare how these treatments affect BTMs and BMD over six months to determine if BTMs can serve as an early and reliable indicator of treatment success, which could be particularly useful in regions like Pakistan where access to repeated DEXA scans is limited.",[27,64],[167,168,169,170],"Bone Turnover Markers","Bone Density","Postmenopausal Osteoporosis","DEXA Scan","2025-11-17",{"date":173,"type":40},"2025-11-21",{"date":175,"type":40},"2025-10-01",{"date":177,"type":21},"2026-04-15",{"name":179,"class":47},"Khyber Medical University Peshawar",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100595567","evaluation-of-osteo-buddy-in-improving-osteoporosis-knowledge-100595567","NCT07034131","Evaluation of Osteo-Buddy in Improving Osteoporosis Knowledge","Improving Both Health in Women With the Use of Osteo-Buddy to Enhance Osteoporosis Knowledge - A Mixed Method Clinical Trial","Inclusion Criteria:\n\n* Age 50 and above\n* Medium or high Osteoporosis Self-Assessment Tool for Asians (OSTA) score\n* Not undertaken Bone Mineral Density (BMD) scan\n* Never been treated with anti-osteoporosis medications such as bisphosphonates (e.g. alendronate, risendronate, ibandronate, zolendronate, pamidronate) or denosumab\n* Able to read and speak English\n* Currently use and own a smartphone where Osteo-Buddy can be used\n\nExclusion Criteria:\n\n* Known terminal illness\n* Visual, hearing and\u002For cognitive impairment or mental illness that renders them unable to provide informed consent",{"count":188,"type":21},80,[83],"This is a pilot randomised controlled trial (RCT) to evaluate the use of a Virtual Health Assistant (VHA) named Osteo-Buddy in improving the knowledge of osteoporosis in older women.",[192,64],"Osteoporosis Risk","2025-06-26",{"date":195,"type":40},"2025-07-01",{"date":197,"type":21},"2025-07",{"date":199,"type":21},"2026-03",{"name":201,"class":47},"SingHealth Polyclinics",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100528747","sequential-therapies-after-osteoanabolic-treatment-100528747","NCT06164795","Sequential Therapies After Osteoanabolic Treatment","Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide\u002FAbaloparatide (START) Study","START","Inclusion Criteria:\n\n• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide\n\nExclusion Criteria:\n\n* a bone disease other than postmenopausal osteoporosis\n* use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study\n* creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* liver failure\n* any type of cancer\n* uncontrolled endocrine diseases\n* serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng\u002FmL (50 nmol\u002FL)\n* hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients","85 Years",{"count":212,"type":21},150,"OBSERVATIONAL","12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics",[64],"2025-04-24",{"date":218,"type":40},"2025-04-27",{"date":220,"type":40},"2023-11-25",{"date":222,"type":21},"2027-05",{"name":224,"class":47},"424 General Military Hospital",8,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":210,"enrollmentInfo":234,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100483448","single-or-repeat-zoledronate-versus-alendronate-following-denosumab-european-denosumab-effects-consolidation-study-100483448","NCT05575167","Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)","The Effectiveness of Single or Repeat Zoledronate Infusion Versus Oral Alendronate in Consolidating the Bone Accrual Achieved With Denosumab: a Study Organised by the European Calcified Tissue Society","EURODEC","Inclusion Criteria:\n\n• Postmenopausal women treated with denosumab for 3 or more years who will reach osteopenia\n\nExclusion Criteria:\n\n* a bone disease other than postmenopausal osteoporosis\n* use of medications other than bisphosphonates or SERMS affecting bone metabolism during the last 12 months before entering the study\n* creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* liver failure\n* any type of cancer\n* uncontrolled endocrine diseases\n* serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng\u002FmL (50 nmol\u002FL)",{"count":235,"type":21},125,"A 24-month prospective, open-label, randomized, multicenter, multinational, non-inferiority pragmatic clinical trial evaluating zoledronate single or double infusion versus oral alendronate following denosumab",[64],{"date":218,"type":40},{"date":240,"type":40},"2023-11-28",{"date":242,"type":21},"2027-11",{"name":224,"class":47},9,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":210,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100578324","phase-2-efficacy-of-osteobor-in-postmenopausal-osteoporosis-100578324","NCT06809816","Efficacy of OsteoBor in Postmenopausal Osteoporosis","Efficacy of OsteoBor in Postmenopausal Osteoporosis: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial","Inclusion Criteria:\n\nAge Range: Postmenopausal women aged 45 to 85 years. Menopause status must be confirmed, with at least 1 year since the last menstrual period.\n\nBone Mineral Density (BMD): T-score at the lumbar spine, total hip, or femoral neck should be ≤ -2.5 but \\> -3.5.\n\nGeneral Health: Participants must be generally healthy with no significant chronic diseases that could affect bone health or the assessment of outcomes.\n\nCompliance with OsteoBor: All participants must be willing to adhere to daily intake of OsteoBor or placebo, along with calcium (1200 mg) and vitamin D (800 IU) supplements throughout the study.\n\nInformed Consent: Participants must sign written informed consent before enrolment and confirm their understanding of the study design, interventions, and potential risks.\n\n\\-\n\nExclusion Criteria:\n\nHistory of Fractures: A history of hip fractures or more than one clinical fracture in the spine. Any fractures other than hip fractures (except for fractures of fingers, toes, or the skull) within the past 24 months.\n\nOther Bone Diseases: Presence of metabolic bone disorders other than osteoporosis, such as Paget's disease, osteomalacia, or hyperparathyroidism. Rheumatoid arthritis or other inflammatory joint diseases that could affect bone health.\n\nKidney-Liver Problems \\& Calcium Metabolism: Severe kidney failure, defined as serum creatinine levels above 1.6 mg\u002FdL, or a history of kidney stones. Abnormalities in serum calcium levels, 25-hydroxy vitamin D, or parathyroid hormone (PTH) levels.\n\nProhibited Medications: Use of oral bisphosphonates in the past 6 months or long-term use (more than 6 months) at any time in the past. Any use of IV bisphosphonates, including zoledronate, in the year prior to the study. Use of denosumab, teriparatide, or any anabolic bone drug within the past 12 months. Use of systemic glucocorticoids (equivalent to more than 5 mg\u002Fday of prednisone) for over 2 weeks in the past 6 months. Use of active vitamin D, strontium ranelate, or other investigational bone health agents in the past 3 months.\n\nChronic Diseases: Diseases affecting bone metabolism or physical mobility, such as uncontrolled thyroid disease, uncontrolled diabetes, or severe gastrointestinal disorders that affect nutrient absorption. Any conditions that cause persistent tremors that might interfere with imaging or medication adherence.\n\nPrevious Participation in Other Studies: Recent participation in clinical trials involving investigational drugs or supplements for bone health within the past 12 months.\n\nAlcohol and Drug Use: Heavy alcohol consumption (\\>2 drinks\u002Fday) or substance abuse that could affect study compliance and bone health.\n\nAllergies and Sensitivities: Known allergies or sensitivities to boron supplements, calcium, vitamin D, or other components of the study drugs.\n\n\\-",{"count":253,"type":21},30,[255],"PHASE2","This study aims to evaluate the impact of boron supplementation (OsteoBor) on bone health in postmenopausal women. The trial is a phase 2, randomised, double-blind, placebo-controlled study lasting one year",[64],"2025-01-30",{"date":260,"type":40},"2025-02-05",{"date":262,"type":21},"2025-03-01",{"date":264,"type":21},"2025-09-01",{"name":266,"class":47},"Tabriz University of Medical Sciences",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":274,"enrollmentInfo":275,"targetDuration":277,"studyType":213,"phases":4,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":48},"100566478","stress-urinary-incontinence-and-sarcopenia-in-postmenopausal-osteoporosis-100566478","NCT06655701","Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis","Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis: The Intersection of Muscle Loss and Pelvic Dysfunction","Inclusion Criteria:\n\n* Postmenopausal women with DXA measurements performed within the last 6 months.\n* Based on DXA measurements:\n\nFemoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).\n\nFemoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.\n\n* Aged 50-75 years\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.\n* Presence of psychiatric disorders.\n* Cognitive impairments.\n* Use of medications that could affect the study results.","75 Years",{"count":276,"type":21},100,"1 Day","The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.",[64],"2024-12-09",{"date":282,"type":40},"2024-12-12",{"date":284,"type":40},"2024-11-15",{"date":286,"type":21},"2025-01-15",{"name":288,"class":47},"Beylikduzu State Hospital",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":48},"100551649","health-literacys-impact-on-exercise-habits-and-medication-adherence-in-postmenopausal-osteoporosis-100551649","NCT06462833","Health Literacy's Impact on Exercise Habits and Medication Adherence in Postmenopausal Osteoporosis","The Relationship Between Health Literacy, Exercise Habits, and Medication Adherence in Postmenopausal Osteoporosis Patients","Inclusion Criteria:\n\n* Postmenopausal patients\n* Being under outpatient follow-up for osteoporosis for at least one year\n\nExclusion Criteria:\n\n* Orthopedic, rheumatic, and neurological conditions that may hinder participation in exercise\n* Cancer\n* Refusal to participate in the study",{"count":103,"type":21},"Postmenopausal osteoporosis is characterized by low bone mass and increased fracture risk. Treatment includes exercise, nutrition, supplements, and medications like bisphosphonates, denosumab, or hormone replacement therapy. Lifestyle changes such as quitting smoking, reducing alcohol consumption, and preventing falls are also crucial.\n\nDespite effective treatments, adherence is low: 20-30% of patients don't start oral bisphosphonates, and 16-60% continue medications after one year. Exercise adherence rates are similarly low (14.3%-57.7%). This non-adherence imposes a significant clinical and economic burden.\n\nHealth literacy (HL)-the ability to find, understand, and use health information-is vital for managing health but is understudied in relation to osteoporosis treatment adherence. This study aims to examine the relationship between HL, exercise habits, and medication adherence in postmenopausal osteoporosis patients. Understanding these factors can lead to effective interventions, improving patient adherence and health outcomes.\n\nThe study will measure HL levels and their correlation with medication and exercise adherence, potentially informing health education programs and strategies to enhance treatment adherence. By doing so, it aims to improve health outcomes and healthcare system efficiency.",[64],[300,301,302,138],"Health Literacy","Medication Adherence","Exercise","2024-09-24",{"date":305,"type":40},"2024-09-26",{"date":307,"type":40},"2024-07-01",{"date":309,"type":21},"2024-10",{"name":311,"class":47},"Gazi University",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":48},"100556483","new-biomarkers-and-therapeutic-targets-in-osteoporosis-via-omics-technologies-100556483","NCT06525688","New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies","Identification of New Biomarkers and Potential Therapeutic Targets in Clinical Osteoporosis Using Omics Technologies","Inclusion Criteria:\n\n* Postmenopausal Female Patients with osteoporotic subcapital femoral neck fracture (Arm 1)\n* Postmenopausal Female Patients with hip osteoarthritis that will undergo Total Hip Replacement (Arm 2)\n\nExclusion Criteria:\n\n* Patients that have undergone before osteoporotic fractures\n* Patients with severe cardiovascular, pulmonary, autoimmune, or urinary system conditions",{"count":103,"type":21},"This study aims to discover novel biomarkers and therapeutic targets for osteoporosis through the use of advanced omics technologies, including proteomics and metabolomics. By analyzing bone and plasma samples from patients with osteoporosis, the research seeks to understand the underlying mechanisms of the disease and identify potential diagnostic and therapeutic biomarkers.",[64,322,323],"Osteoporosis Fracture","Osteoporosis, Severe",[27,325,326,169,327,328,329],"Osteoarthritis","Hip fracture","Proteomics","Metabolomics","Osteoporotic Hip Fracture","2024-07-24",{"date":332,"type":40},"2024-07-29",{"date":334,"type":40},"2024-07-03",{"date":336,"type":21},"2025-12-30",{"name":338,"class":47},"National and Kapodistrian University of Athens",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":57,"sex":160,"minAge":129,"maxAge":4,"enrollmentInfo":346,"targetDuration":17,"studyType":213,"phases":4,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":48},"100553518","virtual-peri-menopause-registry-of-australia-100553518","NCT06487130","Virtual perI-\u002FMenopause Registry of AusTrALia","VITAL","Inclusion Criteria:\n\n* Any Australian over 18 years of age.\n\nExclusion Criteria:\n\n* None.",{"count":347,"type":21},10000,"13 million (50.7%) Australians are born with ovaries, 14% (\\~3 million) are currently aged 40-59 yrs, \\& all such who live to midlife will experience menopause, defined as \\>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression\u002Fanxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \\& urinary urgency. These symptoms are linked with lower quality of life \\& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \\& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \\& dementia are also associated with menopause, yet it remains disconcertingly poorly studied.\n\nThe investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-\u002Fmenopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \\& mental health symptoms, \\& to direct priorities for research, education, \\& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \\& impact.\n\nThe participating consumers, researchers, clinical specialists, policy makers, \\& modern virtual data infrastructure enable this unique \\& innovative registry design, future translation to improved community health, \\& promote awareness \\& collaborative synergies. Leveraging the investigators' critical range of expertise \\& ongoing feedback opportunities for both participants \\& stakeholder partnerships, the investigators will create a ground-breaking platform that:\n\n* empowers the consumer voice and priorities,\n* enables peri-\u002Fmenopause research to extend beyond existing niche focuses,\n* evidences the true impact of peri-\u002Fmenopause across the nation,\n* evolves healthcare services and outcomes, \\&\n* educates community, clinicians, \\& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \\& apply the best aspects of care from across the world.",[350,351,352,353,354,355,356,357,358,359,64,360,361,362,363,364,365,366,367,368],"Menopause","Perimenopausal Disorder","Postmenopausal Symptoms","Health Knowledge, Attitudes, Practice","Healthy Aging","Health Care Utilization","Health Care Seeking Behavior","Mental Health Impairment","Mental Deterioration","Mental Health Issue","Diabetes Mellitus Risk","Diabetes Mellitus, Type 2","Dementia","Cardiovascular Diseases","Menopause Related Conditions","Hot Flashes","Hot Flushes Aggravated","Economic Burden","Social Stigma","2024-07-02",{"date":371,"type":40},"2024-07-05",{"date":373,"type":40},"2023-08-03",{"date":375,"type":21},"2073-08",{"name":377,"class":378},"Bespoke Clinical Research","INDUSTRY",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":48},"100456797","vascular-function-sarcopenia-and-pain-in-postmenopausal-osteoporosis-100456797","NCT05228262","Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis","Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis","VASCO","Inclusion Criteria:\n\n* Women aged 50 years or older with postmenopausal osteoporosis, whether fractured or not, requiring initiation of treatment with antiosteoporotic drugs (bisphosphonates, raloxifene, teriparatide, denosumab and others to come for this indication, including romosozumab), either orally or by injection, as part of their care and management.\n* Able to give informed consent to participate in research.\n* Affiliation to a Social Security system.\n\nExclusion Criteria:\n\n* Patient with chronic renal failure, defined as glomerular filtration rate \\\u003C 30 mL.min-1 estimated by CKD-EPI.\n* Patient with a medical and\u002For surgical history deemed by the investigator or his\u002Fher representative to be incompatible with the trial.\n* Patient under legal protection or deprived of liberty.\n* Refusal to participate.",{"count":212,"type":21},[83],"This study aims to follow a cohort of osteoporotic patients treated with anti-osteoporotic drugs and to evaluate the impact of these treatments on the osteoporosis-cardiovascular-sarcopenia triad and on pain.",[64],[27,392,393,394],"Sarcopenia","Cardiovascular","FMD","2022-10-06",{"date":397,"type":40},"2022-10-10",{"date":399,"type":40},"2022-02-15",{"date":401,"type":21},"2027-02-01",{"name":403,"class":47},"University Hospital, Clermont-Ferrand"]