204 completed. 204 Phase 3, 10 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 204 | Completed 204 |
| Phase 2 | 10 | Completed 10 |
Follow Osteoporosis: new trials by email Literature Review of Osteoporosis trials Research Report on Osteoporosis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND AVT03, Denosumab - Osteoporosis, Postmenopausal | Phase 3 | Completed | Alvotech Swiss AG | 532 | 2022-08-23 | 2025-05-29 |
| A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® ENZ215, Prolia - Postmenopausal Osteoporosis | Phase 3 | Completed | Enzene Biosciences Ltd. | 504 | 2022-07-04 | 2026-02-10 |
| A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis Romosozumab, Placebo - Osteoporosis | Phase 3 | Completed | UCB Biopharma SRL | 327 | 2021-10-21 | 2026-09-28 |
| Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis RGB-14-P, Prolia® - Postmenopausal Osteoporosis | Phase 3 | Completed | Gedeon Richter Plc. | 473 | 2021-09-21 | 2024-10-24 |
| A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis FKS518, US-licensed Prolia (Amgen) - Postmenopausal Osteoporosis | Phase 3 | Completed | Fresenius Kabi SwissBioSim GmbH | 553 | 2021-06-16 | 2025-02-27 |
| Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® . CMAB807 Injection, Prolia® - Postmenopausal Osteoporosis | Phase 3 | Completed | Shanghai Biomabs Pharmaceutical Co., Ltd. | 278 | 2021-03-31 | 2025-02-20 |
| A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis TVB-009, Prolia® - Osteoporosis, Postmenopausal | Phase 3 | Completed | Teva Pharmaceuticals USA | 332 | 2021-03-22 | 2026-10-01 |
| A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab) - Postmenopausal Osteoporosis | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 457 | 2020-11-26 | 2025-02-04 |
| Efficacy and Safety of MW031 in PMO Subjects MW031, Placebo - Osteoporosis, Postmenopausal | Phase 3 | Completed | Mabwell (Shanghai) Bioscience Co., Ltd. | 448 | 2019-12-27 | 2023-10-11 |
| Alendronate Versus Denosumab in Kidney Transplant Patients Denosumab 60 mg/ml [Prolia], Alendronate 70Mg Tab - Osteoporosis, Osteopenia, Renal Transplant Recipient | Phase 2 / Phase 3 | Completed | Ain Shams University | 90 | 2019-10-17 | 2021-11-12 |
| DPP4-Inhibitors and Bone Metabolism in Diabetes Sitagliptin 100 mg, Placebo Tablets - Osteoporosis, Bone Loss, Postmenopausal | Phase 3 | Completed | Azienda Policlinico Umberto I | 132 | 2019-09-24 | 2025-01-13 |
| Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis abaloparatide, abaloparatide solid microstructured transdermal system - Postmenopausal Osteoporosis | Phase 3 | Completed | Radius Health, Inc. | 511 | 2019-08-05 | 2023-02-15 |
| Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis GP2411, EU-Prolia (EU-authorized Prolia®) - Postmenopausal Women With Osteoporosis | Phase 3 | Completed | Sandoz | 527 | 2019-07-02 | 2023-03-08 |
| Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption Abaloparatide - Osteoporosis, Postmenopausal, Osteoporosis | Phase 3 | Completed | Radius Health, Inc. | 23 | 2018-09-20 | 2021-10-15 |
| Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis Denosumab, Placebo - Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis | Phase 3 | Completed | Amgen | 24 | 2018-05-07 | 2024-07-19 |
| Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM) Abaloparatide, Placebo - Osteoporosis, Osteoporosis, Age-Related | Phase 3 | Completed | Radius Health, Inc. | 228 | 2018-05-03 | 2023-04-07 |
| Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis Denosumab, Placebo - Osteoporosis, Systemic Mastocytosis | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 24 | 2018-03-05 | 2026-03-31 |
| A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis romosozumab HCP administration with PFS, romosozumab self-administration with AI/Pen - Post-Menopausal Osteoporosis | Phase 3 | Completed | Amgen | 283 | 2018-02-06 | 2020-11-23 |
| A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis Romosozumab, Placebo - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 67 | 2017-01-16 | 2019-10-07 |
| Selenium for Musculoskeletal Health selenase (selenium) - Osteoporosis | Phase 3 | Completed | Sheffield Teaching Hospitals NHS Foundation Trust | 123 | 2017-01-01 | 2022-01-06 |
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Osteoporosis, Postmenopausal (67) · Bone Diseases, Metabolic (41) · Fractures, Bone (12) · Breast Neoplasms (11) · Prostatic Neoplasms (6) · Bone Diseases (5) · Motor Activity (5) · Hip Fractures (4) · Osteoporotic Fractures (4) · Spinal Fractures (4) · Back Pain (3) · Cardiovascular Diseases (3) · Hypertension (3) · Musculoskeletal Diseases (3)
Metabolic Diseases (204) · Nutritional and Metabolic Diseases (204) · Musculoskeletal Diseases (201) · Bone Diseases (199) · Bone Diseases, Metabolic (163) · Wounds and Injuries (23) · Neoplasms (21) · Neoplasms by Site (19) · Urogenital Diseases (14) · Pathological Conditions, Signs and Symptoms (13) · Genital Diseases (12) · Skin Diseases (12) · Skin and Connective Tissue Diseases (12) · Breast Diseases (11)
Denosumab (30) · Alendronate (27) · Risedronic Acid (23) · Zoledronic Acid (23) · Teriparatide (22) · Vitamin D (15) · Calcium (12) · Cholecalciferol (12) · Ibandronic Acid (10) · Duration of Therapy (8) · Calcium Carbonate (7) · romosozumab (7) · Estrogens, Conjugated (USP) (5) · Raloxifene Hydrochloride (5) · bazedoxifene (5)
Amgen (21) · Eli Lilly and Company (19) · Novartis Pharmaceuticals (14) · Organon and Co (12) · Hoffmann-La Roche (6) · Radius Health, Inc. (5) · Alliance for Clinical Trials in Oncology (4) · Merck Sharp & Dohme LLC (4) · Novartis (4) · Sanofi (4) · Shire (4) · Warner Chilcott (4) · Columbia University (3) · GlaxoSmithKline (3) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (3)
United States (86) · Canada (40) · Poland (34) · Australia (23) · Italy (23) · Spain (23) · Hungary (22) · Argentina (21) · Czechia (21) · France (21) · Denmark (20) · Belgium (19) · Germany (19) · Mexico (15) · United Kingdom (14)
B. Cathy Craven, MD, FRCPC (2) · Dawn Hershman, MD (2) · Elizabeth Shane, MD (2) · Philip D Chilibeck, PhD (2) · Project Leader, Development Planning (2)
PMID 38979716, PMID 21037195, PMID 31776637, PMID 20533525, PMID 22152181, PMID 31411768, PMID 31674644, PMID 32658264, PMID 34231877, PMID 36588166, PMID 38573517, PMID 15647811, PMID 16467232, PMID 16467233, PMID 16467234, PMID 16481635, PMID 16481636, PMID 16609086, PMID 16684825, PMID 16880313, PMID 16973975, PMID 17244788, PMID 17277040, PMID 17339618, PMID 17341712, PMID 17371886, PMID 17405972, PMID 17476007, PMID 17502530, PMID 17556697, PMID 17577003, PMID 17582069, PMID 17878149, PMID 17904460, PMID 17925539, PMID 18003959, PMID 18035193, PMID 18235052, PMID 18299491, PMID 18319414, PMID 18381571, PMID 18489937, PMID 18502208, PMID 18625626, PMID 18663162, PMID 18689371, PMID 18697901, PMID 18703472, PMID 18711172, PMID 18767928
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