[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporotic-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporotic-fractures":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,64,93,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100595042","the-osteoporotic-fracture-classification-based-scoring-system-for-treatment-decision-in-thoracolumbar-osteoporotic-fractures-100595042",false,"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","ALL","50 Years",{"count":19,"type":20},648,"ESTIMATED","OBSERVATIONAL","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).",[24,25],"Osteoporotic Fractures","Osteoporosis","RECRUITING","2026-05-11",{"date":29,"type":30},"2026-05-13","ACTUAL",{"date":32,"type":30},"2026-03-19",{"date":34,"type":20},"2030-12-01",{"name":36,"class":37},"AO Foundation, AO Spine","OTHER",15,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100551053","restore-reducing-future-fractures-and-improving-outcomes-of-fragility-fracture-100551053","NCT06455085","RESTORE: REducing Future fractureS and Improving ouTcOmes of fRagility fracturE","RESTORE","Inclusion Criteria:\n\n* Age 50 years and older (no upper age limit)\n* Sustained a primary fragility fracture (hip\u002Ffemur, pelvis, clinical spine, humerus, wrist) in the last 12 months\n* Participant must self-identify a regular primary care provider (PCP)\n* Participant must provide a mailing address\n* Participant must plan to remain geographically proximate (able to travel if necessary) to the site from which they are recruited over the next several months\n\nExclusion Criteria:\n\n* Exposure to the following medications in the prior 12 months;\n* Actonel or Atelvia (risedronate)\n* Fosamax or Binosto (alendronate)\n* Reclast, Zometa, or Aclasta (zoledronic acid, zoledronate)\n* Boniva or Bondronat (ibandronate)\n* Aredia (pamidronate)\n* Prolia (denosumab)\n* Evenity (romozosumab)\n* Tymlos (abaloparatide)\n* Forteo (teriparatide)\n* Natpara (parathyroid hormone)\n* Evista (raloxifene)\n* Duavee (bazedoxifene-conjugated estrogen)\n* Miacalcin (calcitonin)\n* Diagnosis of the following medical conditions;\n* CKD stage 4 or 5 or on dialysis\n* Multiple myeloma\n* Addison's disease\n* Adrenal insufficiency\n* Enrolled hospice care\n* Solid organ transplant, or expecting a solid organ transplant\n* Bone marrow transplant\n* History of metabolic bone disease (except osteoporosis) such as Paget's disease, osteomalacia, osteogenesis imperfecta, or Cushing's disease\n* Fractures resulting from severe trauma (e.g. motor vehicle accidents, a fall from 2 feet or higher elevation)\n* Pathologic fractures secondary to malignancy or infection\n* Scheduled appointment with a bone health specialist\n* Participant unable to consent on their own (cognitive impairment, dementia, etc.)\n* Currently enrolled in another research study that requires taking medication",{"count":47,"type":20},2634,"INTERVENTIONAL",[50],"NA","RESTORE tests whether Augmented-FLS, where patients are contacted by a patient navigator (serving as the liaison) and referred to a bone health provider, is better than Enhanced Usual Care, which includes patient and PCP education and activation. We also aim to determine the influence of age, race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies.",[25,24,53],"Fragility Fracture","2026-04-29",{"date":56,"type":30},"2026-05-05",{"date":58,"type":30},"2024-12-16",{"date":60,"type":20},"2029-06-01",{"name":62,"class":37},"University of Alabama at Birmingham",23,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":48,"phases":75,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100505795","study-of-the-key-techniques-of-prevention-and-treatment-of-osteoporotic-refracture-100505795","NCT05866029","Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture","Efficacy of Sequential Denosumab After Teriparatide for 6 Months Compared With Denosumab Monotherapy in Reducing Risk of Osteoporotic Fractures in Patients With New Fractures: a Multicenter Randomized Controlled Trial (STAND Study)","Inclusion Criteria:\n\n1. New brittle hip fractures;\n2. New brittle vertebral fractures;\n3. New other site fractures and\u002For total hip or neck of femur or L1-L4 T-value \\< -1.0;\n4. Men or postmenopausal women;\n5. Age 45-90 years old;\n6. Ability to move autonomously\n\nExclusion Criteria:\n\n1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;\n2. Having primary hyperparathyroidism or hypothyroidism;\n3. Had or have osteomyelitis of the jaw or necrosis of the jaw;\n4. GFR\\\u003C30ml\u002Fmin\u002F1.73m2;\n5. Active infection that requires systematic treatment;\n6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;\n7. Used teriparatide and denosumab for osteoporosis within 6 months;\n8. Used glucocorticoids (equivalent to \\>5 mg\u002Fday prednisone) for more than 10 days within 6 weeks;\n9. The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ;\n10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;\n11. Have hypocalcemia and hypercalcemia;\n12. Unexplained elevation of alkaline phosphatase;\n13. A serious deficiency of vitamin D (25OHD \\<10ng\u002FmL);\n14. Patients who have previously received external radiation or radiation therapy with bone implants;\n15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \\> 8.5%, and severe arrhythmias;\n16. Planned pregnancy and lactation at present or during the study period;\n17. Allergic to teriparatide and denosumab;\n18. Participating in clinical trials of other drugs at present;\n19. subjects do not suitable for this study","45 Years","90 Years",{"count":74,"type":20},2478,[50],"This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.",[24],[79,80,81,82],"osteoporosis","osteoporotic fractures","bone turnover markers","imaging biomarkers","2026-01-07",{"date":85,"type":30},"2026-01-12",{"date":87,"type":30},"2023-05-26",{"date":89,"type":20},"2026-09-30",{"name":91,"class":37},"Peking Union Medical College Hospital",58,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100544338","spine-bone-cements-outcomes---post-market-follow-up-100544338","NCT06367582","Spine Bone Cements Outcomes - Post Market Follow-up","Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up","Inclusion Criteria:\n\n* Be 18 years or older\n* Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study\n\n  o For prospective inclusion:\n* Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study\n\n  o For retrospective inclusion:\n* Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.\n* Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).\n\nExclusion Criteria:\n\nPatients presenting one of the following conditions will not be included (contraindications per IFU):\n\n* Procedures other than those stated in the INDICATIONS section\n* Coagulation disorders, or severe cardiopulmonary disease\n* Unstable vertebral fractures\n* Compromise of the vertebral body or of the pedicle walls\n* Hypersensitivity or allergy to one of the constituents of the product\n* Patient clearly improving on more conservative treatment\n* Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture\n* Paediatric patients and pregnant or breast-feeding women.","18 Years",{"count":102,"type":20},500,"A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.\n\nTEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.",[105,106,24],"Vertebral Fracture","Compression Fracture","2025-09-02",{"date":109,"type":30},"2025-09-09",{"date":111,"type":30},"2019-09-04",{"date":113,"type":20},"2039-09-30",{"name":115,"class":116},"Teknimed","INDUSTRY",12,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":48,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100526933","percutaneous-vertebroplasty-vs-sham-for-osteoporotic-vertebral-compression-fractures-focusing-on-pain-and-economy-100526933","NCT06141187","Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.","Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial","VOPE2","Inclusion Criteria:\n\n* Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).\n* Focal tenderness on the level of the vertebral fracture.\n* Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence\n* Osteoporotic Fractures type 1-4.\n* Fracture involves no more than 4 vertebral body levels.\n* PVP can be done in one session.\n* Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.\n* Able to understand and read Danish.\n* Written informed consent.\n* Relevant pain started ≤ 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* \\- Contra-indications for spine surgery.\n* Platelets \\\u003C 30 mia\u002Fl.\n* Osteoporotic Fractures type 5 and Pincer-type.\n* Complete collapse of the vertebral body precluding insertion of needle.\n* Presence of neurologic deficit.\n* Contraindications for MRI scanning.\n* Psychological or psychiatric disorder that is expected to interfere with compliance.\n* Active malignancy.\n* Mini Mental State Examination (MMSE) test score below 24.\n* History of chronic back pain requiring ongoing opiate use.\n* Systemic or local infection of the spine.",{"count":127,"type":20},240,[50],"The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty.\n\nThe primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.",[24,105],[132,133],"vertebroplasty","Pain","2025-01-03",{"date":136,"type":30},"2025-01-06",{"date":138,"type":30},"2024-01-01",{"date":140,"type":20},"2030-12-31",{"name":142,"class":37},"Spine Centre of Southern Denmark",1]