26 completed, 2 unknown, 1 terminated, 1 withdrawn. 30 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 30 | Completed 26, Unknown 2, Terminated 1, Withdrawn 1 |
Follow Postmenopausal Osteoporosis: new trials by email Literature Review of Postmenopausal Osteoporosis trials Research Report on Postmenopausal 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 |
|---|---|---|---|---|---|---|
| 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 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 & 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 |
| A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture LY06006 - Postmenopausal Osteoporosis | Phase 3 | Unknown | Luye Pharma Group Ltd. | 448 | 2019-06-30 | 2021-09-29 |
| Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk QL1206, Placebos - Postmenopausal Osteoporosis | Phase 3 | Unknown | Qilu Pharmaceutical Co., Ltd. | 440 | 2019-06-05 | 2019-11-06 |
| 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 |
| 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 |
| Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050) Odanacatib, Alendronate, Placebo (odanacatib) - Osteoporosis, Postmenopausal Osteoporosis | Phase 3 | Withdrawn | Merck Sharp & Dohme LLC | 2012-05-01 | 2015-08-27 | |
| Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis Romosozumab, Placebo, Denosumab - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 7180 | 2012-03-15 | 2024-08-28 |
| Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis disodium clodronate 200 mg/4 ml with 1% lidocaine, Disodium clodronate 100 mg/3,3 ml with 1% lidocaine - Postmenopausal Osteoporosis | Phase 3 | Completed | Chiesi Farmaceutici S.p.A. | 260 | 2011-10-01 | 2017-03-30 |
| Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women Placebo, BA058 80 mcg, teriparatide - Osteoporosis, Postmenopausal Osteoporosis | Phase 3 | Completed | Radius Health, Inc. | 2463 | 2011-04-01 | 2017-03-01 |
| A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years Zoledronic acid - Postmenopausal Osteoporosis | Phase 3 | Completed | Novartis Pharmaceuticals | 118 | 2009-11-01 | 2017-03-21 |
| A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates Ibandronate, Denosumab - Postmenopausal Osteoporosis | Phase 3 | Completed | Amgen | 833 | 2009-07-01 | 2013-02-11 |
| A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab high-resolution peripheral quantitative computed tomography (HR-pQCT), Dual energy X-ray absorptiometry (DXA), Denosumab - Low Bone Mass, Low Bone Mineral Density | Phase 3 | Completed | Amgen | 79 | 2009-07-01 | 2014-04-02 |
Showing 20 of 30. Sign in to see all of them.
Osteoporosis, Postmenopausal (30) · Osteoporosis (14) · Bone Diseases, Metabolic (6) · Fractures, Bone (3) · Bone Diseases (2) · Musculoskeletal Diseases (2) · Motor Activity (1)
Metabolic Diseases (30) · Nutritional and Metabolic Diseases (30) · Bone Diseases (28) · Musculoskeletal Diseases (28) · Bone Diseases, Metabolic (24) · Osteoporosis (16) · Wounds and Injuries (3) · Behavior (1)
Denosumab (11) · Alendronate (5) · Risedronic Acid (4) · romosozumab (4) · Calcium Carbonate (2) · Cholecalciferol (2) · Ibandronic Acid (2) · QL1206 (2) · Teriparatide (2) · abaloparatide (2) · odanacatib (2) · Absorptiometry, Photon (1) · Calcium (1) · Clodronic Acid (1) · Duration of Therapy (1)
Amgen (9) · Organon and Co (3) · Radius Health, Inc. (3) · Warner Chilcott (3) · Merck Sharp & Dohme LLC (2) · Chiesi Farmaceutici S.p.A. (1) · Eisai Co., Ltd. (1) · Enzene Biosciences Ltd. (1) · Fresenius Kabi SwissBioSim GmbH (1) · Gedeon Richter Plc. (1) · Luye Pharma Group Ltd. (1) · Novartis Pharmaceuticals (1) · Qilu Pharmaceutical Co., Ltd. (1) · Samsung Bioepis Co., Ltd. (1) · Shanghai Biomabs Pharmaceutical Co., Ltd. (1)
Poland (14) · United States (10) · Czechia (8) · Denmark (7) · Hungary (7) · Argentina (6) · Estonia (6) · Spain (6) · Canada (5) · Belgium (4) · Brazil (4) · China (4) · Lithuania (4) · Australia (3) · Bulgaria (3)
Ana Balske, MD, PhD (1) · Bruce Mitlak (1) · Dietrich H Wenderoth, MD (1) · Hong Di (1) · Sal Bartelmo, MD (1) · Zhenlin Zhang, doctor (1)
PMID 31411768, PMID 31674644, PMID 31776637, PMID 32658264, PMID 36588166, PMID 18381571, PMID 19345291, PMID 19594293, PMID 20533525, PMID 21289258, PMID 21947137, PMID 22152181, PMID 23812464, PMID 27533157, PMID 27612281, PMID 27826127, PMID 28160873, PMID 29800372, PMID 31676222, PMID 32119749, PMID 32513495, PMID 32665529, PMID 32935170, PMID 33677928, PMID 33724542, PMID 34231877, PMID 35711006, PMID 37417725, PMID 38573517, PMID 39243386, PMID 39674388, PMID 39999474, PMID 40786602