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Also known as Romosozumab Prefilled Syringe [Evenity], Romosozumab
Romosozumab Prefilled Syringe · 2 trials · 5 indications
Percent change from baseline to 12 months in postero-anterior lumbar spine bone mineral density by dual energy x-ray absorptiometry (DXA).
Within-group percent change in lumbar spine BMD by DXA at 12M
| Arm | Type | Description |
|---|---|---|
| Active Romosozumab 210mg Injection | EXPERIMENTAL | Romosozumab 210mg injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab. |
| Placebo | PLACEBO_COMPARATOR | Placebo injection monthly for 12 months. A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of placebo. |
| Romosozumab followed by denosumab | EXPERIMENTAL | Romosozumab 210 mg subcutaneous injection, once a month for 12 months followed by denosumab 60 mg subcutaneous injection, once every six months for 12 months. |
| Name | Type | Description |
|---|---|---|
| Romosozumab Prefilled Syringe | DRUG | Romosozumab 210mg Injection monthly for 12 months |
| Placebo | DRUG | Placebo Injection monthly for 12 months |
| Zoledronic acid 5 mg | DRUG | A single infusion of open-label zoledronic acid 5 mg after the initial 12-month administration of romosozumab or placebo |
| Romosozumab Prefilled Syringe [Evenity] | DRUG | 2 syringes of 105 MG/1.17 mL subcutaneous solution injected one after the other, once a month from study baseline through 11 month visit |
| Denosumab 60 MG/ML Prefilled Syringe [Prolia] | DRUG | 1 subcutaneous injection of 60 mg/mL every six months from study 12 month visit through the 24 month visit. Injections occur at the 12 and 18 month visits. |
Inclusion Criteria: * Female * Age 20-60 years, skeletally mature with closed epiphyses * Body mass index (BMI) ≥ 16.5 kg/m2 * Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria * BMD Z-score \< -1.0 * Normal serum 25-OH vitamin D (\>30 ng/mL) and calcium levels * Fo...
Romosozumab is a monoclonal antibody being developed for musculoskeletal conditions including postmenopausal osteoporosis, osteogenesis imperfecta, osteopenia, and premenopausal idiopathic osteoporosis. It is currently in Phase 2 clinical development for premenopausal idiopathic osteoporosis, with earlier studies completed in osteopenia.
Romosozumab is developed by Amgen Inc., traded on NASDAQ under the ticker AMGN. The company is conducting clinical trials to evaluate the drug for osteoporosis-related conditions.
Romosozumab is in Phase 2 clinical development. One active Phase 2 trial is studying the drug in premenopausal idiopathic osteoporosis, while three Phase 1 trials have been completed in osteopenia. It is investigational and not yet approved.
Romosozumab has four clinical trials. The active Phase 2 trial is NCT04800367 for premenopausal idiopathic osteoporosis. Completed Phase 1 trials include NCT00950950, NCT01059435, and NCT01101061, all studying osteopenia in postmenopausal women or healthy participants.
Romosozumab is also known as Romosozumab Prefilled Syringe [Evenity] and Romosozumab Prefilled Syringe. These names refer to the same drug product, which is being developed by Amgen for osteoporosis-related conditions.