154 completed, 40 unknown, 21 terminated, 19 recruiting. 78 Phase 3, 77 Phase 2, 54 Phase 4, 40 Phase 1, 9 Not applicable.
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 |
|---|---|---|---|---|---|---|
| Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD Romosozumab, Zoledronic Acid 5 MG in 5 ML Injection, Calcium 500 mg and Vitamin D3 800 IU - Osteoporosis in Post-menopausal Women | Phase 4 | Not yet recruiting | Sahlgrenska University Hospital | 216 | 2027-01-11 | 2026-08-19 |
| 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 of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass Denosumab, Placebo - Postmenopausal Osteoporosis, Low Bone Mass | Phase 2 | Not yet recruiting | Transcenta Therapeutics (Hangzhou) Co., Ltd. | 110 | 2026-10-31 | 2026-09-11 |
| Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Clinical Trial at 6 Years Romosozumab, Denosumab - Glucocorticoid-Associated Osteopenia and Osteoporosis | Phase 4 | Not yet recruiting | Tuen Mun Hospital | 54 | 2026-09-01 | 2026-08-12 |
| Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases Zanzalintinib, Investigator Choice of Bone Strengthening Agents (BSA), Non-Investigational Radiation Therapy (RT) - Clear Cell Renal Cell Cancer (ccRCC), Clear Cell Renal Carcinoma | Phase 2 | Recruiting | Kelly Fitzgerald, MD | 20 | 2026-06-10 | 2026-07-27 |
| Denosumab Strategy for Liver Cancer With Bone Metastases Denosumab, Sintilimab, Delayed/Rescue Bone-Modifying Strategy - Hepatocellular Carcinoma (HCC), Bone Metastases | Phase 2 | Not yet recruiting | Tongji Hospital | 50 | 2026-05-01 | 2026-04-17 |
| Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis Denosumab, Romosozumab - Osteoporosis | Phase 4 | Recruiting | National Taiwan University Hospital | 90 | 2025-12-03 | 2025-12-16 |
| 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 | |
| Clinical Relevance of Modifying RANKL Signaling During Folliculogenesis Denosumab, PBS - Female Infertility, NF-κB Ligand | Not applicable | Recruiting | Peter Humaidan | 100 | 2025-08-01 | 2026-04-22 |
| A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches Microneedle with 0.24mg Denosumab, Saline Microneedle Patch, Microneedle with 1.2mg Denosumab - Osteoarthritis, Osteoarthritis (OA) of the Knee | Phase 1 | Not yet recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 12 | 2025-07-31 | 2025-07-25 |
| 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 for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China Prolia® - Glucocorticoid-induced Osteoporosis | Phase 4 | Active not recruiting | Amgen | 102 | 2025-05-24 | 2026-05-27 |
| Denosumab for Type 1 Diabetes Denosumab, Placebo - Type 1 Diabetes | Phase 1 / Phase 2 | Recruiting | City of Hope Medical Center | 45 | 2025-05-05 | 2026-10-20 |
| NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia Denosumab (Prolia), Letrozole (Aromatase Inhibitors) - Infertility, Male | Phase 1 / Phase 2 | Completed | Martin Blomberg Jensen | 16 | 2025-03-01 | 2026-10-21 |
| Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis Zumsemetinib, Capecitabine, Zoledronic acid - Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer | Phase 1 / Phase 2 | Recruiting | Washington University School of Medicine | 152 | 2025-01-30 | 2026-10-13 |
| Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures Romosozumab and Denosumab Combination Therapy, Romosozumab Prefilled Syringe [Evenity], Denosumab (Prolia) - Osteoporosis in Post-menopausal Women | Phase 4 | Not yet recruiting | Marmara University | 60 | 2025-01-15 | 2024-12-27 |
| ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers ETC-159, Pembrolizumab, Denosumab / Zoledronic Acid - With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer | Phase 1 | Recruiting | National University Hospital, Singapore | 16 | 2024-12-09 | 2025-07-25 |
| An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting Denosumab, tislelizumab, Docetaxel - Lung Cancer | Phase 2 | Recruiting | Shanghai Pulmonary Hospital, Shanghai, China | 22 | 2024-11-19 | 2024-12-27 |
| 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 |
| Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months Romosozumab, Denosumab - Osteoporosis, Glucocorticoids Toxicity | Phase 4 | Completed | Tuen Mun Hospital | 54 | 2024-08-20 | 2026-05-05 |
Showing 20 of 268. Sign in to see all of them.
Osteoporosis (79) · Osteoporosis, Postmenopausal (46) · Bone Diseases, Metabolic (27) · Breast Neoplasms (25) · Neoplasms (12) · Giant Cell Tumor of Bone (10) · Fractures, Bone (9) · Multiple Myeloma (9) · Prostatic Neoplasms (9) · Neoplasm Metastasis (8) · Arthritis, Rheumatoid (5) · Bone Diseases (5) · Osteoporotic Fractures (5) · Carcinoma, Non-Small-Cell Lung (4) · Infertility, Male (4)
Amgen (60) · Massachusetts General Hospital (9) · Shenzhen People's Hospital (7) · GlaxoSmithKline (5) · Martin Blomberg Jensen (5) · Luye Pharma Group Ltd. (4) · Mabwell (Shanghai) Bioscience Co., Ltd. (4) · Qilu Pharmaceutical Co., Ltd. (4) · Tuen Mun Hospital (4) · 424 General Military Hospital (3) · Alvotech Swiss AG (3) · James J. Peters Veterans Affairs Medical Center (3) · M.D. Anderson Cancer Center (3) · Shanghai JMT-Bio Inc. (3) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (3)
United States (79) · China (50) · Canada (24) · Poland (24) · France (19) · Czechia (18) · United Kingdom (18) · Australia (17) · Spain (17) · Denmark (15) · Germany (15) · Italy (15) · Greece (12) · Hungary (12) · Belgium (11)
Benjamin Leder, MD (3) · Felicitas Bullo (3) · Steven C Kirshblum, M.D. (3) · Adi Cohen, MD (2) · Alison M Boyce, M.D. (2) · Athanasios D Anastasilakis, MD, PhD (2) · Chi Chiu Mok, MD, FRCP (2) · Elizabeth Shane, MD (2) · Hu Wei, Doctor (2) · Naoto Ueno, MD, PHD (2) · Polyzois Makras, MD, PhD (2) · Rui Niimi, MD (2) · Sam Kafai Yahyavi, MD (2)
PMID 38979716, PMID 22975218, PMID 23975226, PMID 26093811, PMID 31776637, PMID 20533525, PMID 22152181, PMID 25976743, PMID 26335402, PMID 33270906, PMID 34231877, PMID 42643157, PMID 16495394, PMID 17632511, PMID 17708711, PMID 18381571, PMID 18495508, PMID 18539106, PMID 18767928, PMID 19237632, PMID 19345291, PMID 19362675, PMID 19524963, PMID 19594293, PMID 19732857, PMID 21159841, PMID 21289258, PMID 21555773, PMID 21927920, PMID 22093187, PMID 22113951, PMID 23234632, PMID 23683600, PMID 23812464, PMID 23979955, PMID 23990665, PMID 24277854, PMID 24382002, PMID 24420643, PMID 24646104, PMID 24722180, PMID 24848429, PMID 25403903, PMID 25684041, PMID 25761434, PMID 25882205, PMID 25933031, PMID 26070551, PMID 26144908, PMID 26227196
2016 (6), 2014 (3), 2017 (3), 2009 (2), 2018 (2), 2005 (1), 2008 (1), 2015 (1), 2023 (1), I01RX003415 (1), N01CN00034 (1), P30AG024827 (1), P30CA016672 (1), P30CA060553 (1), R01AG052123 (1)