24 completed, 8 recruiting, 6 active not recruiting, 3 not yet recruiting. 14 Phase 4, 10 Phase 1, 10 Phase 3, 9 Phase 2.
Follow romosozumab: new trials by email Literature Review of romosozumab trials Research Report on romosozumab
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 |
| Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections Romosozumab - Healthy Participants | Phase 1 | Recruiting | Amgen | 308 | 2026-09-22 | 2026-10-13 |
| 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 |
| A Study of Romosozumab in People With Breast Cancer and Osteoporosis Romosozumab - Breast Cancer, Metastatic Breast Cancer (MBC) | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 25 | 2026-08-17 | 2026-08-20 |
| Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes Romosozumab, Alendronate (Fosamax), Placebo Romosozumab - Osteoporosis, Post-menopausal | Phase 2 | Withdrawn | University of Pittsburgh | 2026-06-20 | 2026-06-04 | |
| 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 |
| Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects SAL0123, Romosozumab - Osteoporosis | Phase 1 | Enrolling by invitation | Shenzhen Salubris Pharmaceuticals Co., Ltd. | 118 | 2025-10-19 | 2026-02-03 |
| Effects of Cycle Therapy vs Sequential Therapy With Romosozumab and Denosumab in Postmenopausal Osteoporosis Patients Romosozumab followed by Denosumab, Romosozumab and Denosumab Cycle Therapy - Osteoporosis, Osteoporosis Postmenopausal | Phase 4 | Recruiting | National Taiwan University Hospital | 70 | 2025-04-08 | 2026-06-23 |
| Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea Romosozumab, Placebo, Zoledronic acid - FHA (Functional Hypothalamic Amenorrhea) | Phase 3 | Recruiting | Massachusetts General Hospital | 114 | 2025-03-19 | 2026-04-23 |
| Combined Anabolic Therapy Romosozumab, Teriparatide - Osteoporosis, Postmenopausal, Osteoporosis | Phase 4 | Recruiting | Massachusetts General Hospital | 50 | 2025-02-03 | 2026-10-08 |
| 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 |
| 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 |
| Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta Romosozumab, Bisphosphonate - Osteogenesis Imperfecta | Phase 3 | Active not recruiting | Amgen | 111 | 2024-04-22 | 2026-05-27 |
| Sequential Therapies After Osteoanabolic Treatment Zoledronate, Denosumab, Teriparatide - Osteoporosis, Postmenopausal | Recruiting | 424 General Military Hospital | 150 | 2023-11-25 | 2026-07-22 | |
| A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture. Romosozumab - Postmenopausal Osteoporosis | Phase 4 | Completed | Amgen | 100 | 2023-10-30 | 2026-10-21 |
| The Optimised Use of Romozosumab Study Romosozumab, Zoledronate - Osteoporosis | Phase 4 | Recruiting | University of Aarhus | 270 | 2023-10-02 | 2026-07-02 |
| A Study of Romosozumab in Women With Multiple Myeloma and Osteoporosis Romosozumab - Osteoporosis, Multiple Myeloma | Phase 1 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 10 | 2023-03-07 | 2025-12-19 |
| Anabolic Therapy in Postmenopausal Osteoporosis Romosozumab, Denosumab - Postmenopausal Osteoporosis | Phase 4 | Active not recruiting | Massachusetts General Hospital | 50 | 2022-03-24 | 2026-04-15 |
| Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI Romosozumab, Denosumab - Osteoporosis, Spinal Cord Injuries | Phase 4 | Active not recruiting | James J. Peters Veterans Affairs Medical Center | 40 | 2021-11-01 | 2025-09-17 |
| 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 |
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Osteoporosis (22) · Osteoporosis, Postmenopausal (15) · Bone Diseases, Metabolic (11) · Bone Diseases (5) · Musculoskeletal Diseases (4) · Spinal Cord Injuries (4) · Fractures, Bone (2) · Osteogenesis Imperfecta (2) · Osteoporotic Fractures (2) · Breast Neoplasms (1) · Hip Fractures (1) · Multiple Myeloma (1) · Rheumatic Diseases (1) · Spinal Cord Diseases (1)
Amgen (21) · Massachusetts General Hospital (3) · Tuen Mun Hospital (3) · Memorial Sloan Kettering Cancer Center (2) · National Taiwan University Hospital (2) · 424 General Military Hospital (1) · Columbia University (1) · James J. Peters Veterans Affairs Medical Center (1) · Marmara University (1) · Northwestern University (1) · Sahlgrenska University Hospital (1) · Sheba Medical Center (1) · Shenzhen Salubris Pharmaceuticals Co., Ltd. (1) · Susan L. Greenspan (1) · UCB Biopharma SRL (1)
United States (24) · Poland (9) · United Kingdom (8) · Denmark (7) · Hungary (7) · Belgium (6) · Canada (6) · Germany (6) · Italy (6) · Australia (5) · China (5) · Czechia (5) · Greece (5) · Spain (5) · Argentina (4)
Benjamin Leder, MD (2) · Chi Chiu Mok, MD, FRCP (2) · Adi Cohen, MD (1) · Bente Langdahl, MD, Professor, DMSc, PhD, (1) · Canan Sanal, Associate Profesor (1) · Carlyn Tan, MD (1) · Christopher Cardozo, MD (1) · Elizabeth Shane, MD (1) · Liana Tripto-Shkolnik, MD (1) · Mattias Lorentzon, MD, PhD (1) · Nitin Agarwal, M.D. (1) · Steven C Kirshblum, M.D. (1) · Susan L Greenspan, MD (1) · Thomas J Schnitzer, MD, PhD (1)
PMID 38573517, PMID 42470570, PMID 11138687, PMID 24382002, PMID 27641143, PMID 28144701, PMID 29067572, PMID 33677928, PMID 35279261, PMID 35478046, PMID 35787482, PMID 36088628, PMID 36382762, PMID 37574339, PMID 37948565, PMID 38261781, PMID 39485918, PMID 41621431, PMID 42282279
2008 (2), 2017 (2), 2023 (1), I01RX003415 (1), R01AG066825 (1), R21AR083567 (1)