52 completed, 10 unknown, 7 terminated, 3 not yet recruiting. 78 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 78 | Completed 52, Unknown 10, Terminated 7, Not yet recruiting 3, Active not recruiting 2, Recruiting 2, Withdrawn 2 |
| Phase 2 | 4 | Completed 2, Unknown 1, Withdrawn 1 |
Follow Denosumab: new trials by email Literature Review of Denosumab trials Research Report on Denosumab
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 |
|---|---|---|---|---|---|---|
| RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients Denosumab (Prolia), Zoledronic acide (Aclasta) - Sarcopenia in Elderly | Phase 3 | Not yet recruiting | Prince of Wales Hospital, Shatin, Hong Kong | 130 | 2027-01-01 | 2026-09-16 |
| Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® MAB-22, Prolia® - Osteoporosis | Phase 3 | Withdrawn | Xentria, Inc. | 2025-10-01 | 2025-05-11 | |
| A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® QL1206, Prolia® - Postmenopausal Women With Osteoporosis at High Risk of Fracture | Phase 3 | Recruiting | Qilu Pharmaceutical Co., Ltd. | 278 | 2025-06-27 | 2025-07-14 |
| A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis 9MW0311, Prolia® - Postmenopausal Women Osteoporosis | Phase 3 | Completed | Mabwell (Shanghai) Bioscience Co., Ltd. | 280 | 2024-11-16 | 2026-08-07 |
| Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease Narlumosbart, Denosumab - Multiple Myeloma, Bone Diseases | Phase 3 | Not yet recruiting | RenJi Hospital | 478 | 2024-04-01 | 2024-03-18 |
| Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes Denosumab Injection, Normal saline injection (1.0ml/ branch) - Sarcopenia, Osteoporosis | Phase 3 | Unknown | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 86 | 2024-02-01 | 2024-08-16 |
| Comparative Efficacy, Safety, PK, and Immunogenicity Study Denosumab - Osteoporosis, Postmenopausal | Phase 3 | Unknown | Luye Pharma Group Ltd. | 392 | 2023-04-05 | 2024-04-26 |
| A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone Narlumosbart, Denosumab - Giant Cell Tumor of Bone | Phase 3 | Not yet recruiting | Shanghai JMT-Bio Inc. | 146 | 2023-04-01 | 2023-04-19 |
| Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation Denosumab, Placebo, Quality-of-Life Assessment - BRCA1 Mutation, Breast Cancer | Phase 3 | Active not recruiting | Alliance for Clinical Trials in Oncology | 300 | 2023-02-14 | 2026-10-05 |
| 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 Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture HLX14, Prolia® - Postmenopausal | Phase 3 | Completed | Shanghai Henlius Biotech | 514 | 2022-06-17 | 2024-09-20 |
| Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis Bmab 1000, Prolia® - Postmenopausal Women With Osteoporosis | Phase 3 | Completed | Biocon Biologics UK Ltd | 479 | 2022-05-24 | 2025-09-09 |
| Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis Denosumab, Denosumab-Ref - Osteoporosis, Postmenopausal | Phase 3 | Unknown | Lambda Therapeutic Research Ltd. | 552 | 2021-11-11 | 2023-10-13 |
| 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 |
| Denosumab and Screw Fixation for Osteoporotic Compression Fracture Denosumab Only Product - Denosumab Allergy | Phase 2 / Phase 3 | Withdrawn | Shenzhen People's Hospital | 2021-09-14 | 2023-03-14 | |
| Denosumab vs Zoledronic Acid and Osteoporotic Compression Fracture Denosumab, Zoledronic acid - Denosumab vs Zoledronate | Phase 2 / Phase 3 | Unknown | Shenzhen People's Hospital | 122 | 2021-09-08 | 2023-02-21 |
| 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 |
| Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors LY01011, Xgeva® - Bone Metastases From Solid Tumors | Phase 3 | Unknown | Luye Pharma Group Ltd. | 850 | 2021-04-30 | 2021-06-07 |
| 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 |
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Osteoporosis (24) · Osteoporosis, Postmenopausal (21) · Bone Diseases, Metabolic (15) · Breast Neoplasms (9) · Neoplasms (6) · Prostatic Neoplasms (6) · Fractures, Bone (5) · Multiple Myeloma (4) · Bone Diseases (3) · Giant Cell Tumor of Bone (2) · Osteogenesis Imperfecta (2) · Spinal Cord Compression (2) · Anorexia Nervosa (1) · Blood Protein Disorders (1) · Bone Marrow Diseases (1)
Amgen (32) · GlaxoSmithKline (4) · Shenzhen People's Hospital (4) · Luye Pharma Group Ltd. (2) · Mabwell (Shanghai) Bioscience Co., Ltd. (2) · Qilu Pharmaceutical Co., Ltd. (2) · Ain Shams University (1) · Alliance for Clinical Trials in Oncology (1) · Alvotech Swiss AG (1) · AryoGen Pharmed Co. (1) · Assistance Publique - Hôpitaux de Paris (1) · Biocon Biologics UK Ltd (1) · Centre Leon Berard (1) · Daiichi Sankyo Co., Ltd. (1) · ETOP IBCSG Partners Foundation (1)
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