67 completed. 67 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 67 | Completed 67 |
Follow Osteoporosis, Postmenopausal: new trials by email Literature Review of Osteoporosis, Postmenopausal trials Research Report on Osteoporosis, Postmenopausal
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 |
| 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 |
| 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 |
| 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 |
| A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis Denosumab (CP2), Denosumab (CP4) - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 394 | 2014-05-01 | 2017-08-16 |
| Denosumab China Phase III Study Denosumab, Placebo, Elemental Calcium - Osteoporosis, Postmenopausal | Phase 3 | Completed | GlaxoSmithKline | 486 | 2014-01-01 | 2016-10-31 |
| A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis Romosozumab 90 mg/mL, Placebo 90 mg/mL, Romosozumab 70 mg/mL - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 294 | 2013-12-03 | 2018-11-08 |
| An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women Romozosumab, Teriparatide - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 436 | 2013-01-31 | 2022-11-29 |
| Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis Alendronate - Postmenopausal Osteoporosis | Phase 3 | Completed | Radius Health, Inc. | 1139 | 2012-11-20 | 2020-12-11 |
| Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis Romosozumab, Alendronate, Placebo to Romosozumab - Postmenopausal Women With Osteoporosis | Phase 3 | Completed | Amgen | 4093 | 2012-05-04 | 2025-02-21 |
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Osteoporosis (23) · Bone Diseases, Metabolic (11) · Fractures, Bone (5) · Bone Diseases (3) · Musculoskeletal Diseases (3) · Back Pain (1) · Diabetes Mellitus, Type 2 (1) · Motor Activity (1) · Osteoporotic Fractures (1) · Spinal Fractures (1)
Metabolic Diseases (67) · Nutritional and Metabolic Diseases (67) · Bone Diseases (64) · Musculoskeletal Diseases (64) · Bone Diseases, Metabolic (56) · Osteoporosis (44) · Wounds and Injuries (6) · Back Injuries (1) · Behavior (1) · Diabetes Mellitus (1) · Endocrine System Diseases (1) · Fractures, Bone (1) · Glucose Metabolism Disorders (1) · Neurologic Manifestations (1) · Pain (1)
Denosumab (19) · Alendronate (9) · Teriparatide (9) · Risedronic Acid (8) · Ibandronic Acid (6) · romosozumab (6) · Duration of Therapy (4) · Calcium (3) · Injections, Subcutaneous (3) · LY 353381 (3) · Raloxifene Hydrochloride (3) · Vitamin D (3) · Zoledronic Acid (3) · abaloparatide (3) · salmon calcitonin (3)
Amgen (14) · Eli Lilly and Company (11) · Organon and Co (7) · Hoffmann-La Roche (4) · Radius Health, Inc. (4) · GlaxoSmithKline (3) · Novartis Pharmaceuticals (3) · Warner Chilcott (3) · Sanofi (2) · Alvotech Swiss AG (1) · Azienda Policlinico Umberto I (1) · Chiesi Farmaceutici S.p.A. (1) · Eisai Co., Ltd. (1) · Enzene Biosciences Ltd. (1) · Fresenius Kabi SwissBioSim GmbH (1)
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Ana Balske, MD, PhD (1) · Angela M Cheung, MD, PhD (1) · Bruce Mitlak (1)
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