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Also known as AMG 785
Romozosumab · 1 trial · 1 indication
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
| Arm | Type | Description |
|---|---|---|
| Romosozumab | EXPERIMENTAL | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
| Teriparatide | ACTIVE_COMPARATOR | Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. |
| Name | Type | Description |
|---|---|---|
| Romozosumab | DRUG | Administered by subcutaneous injection once a month. |
| Teriparatide | DRUG | Administered by subcutaneous injection once a day. |
Inclusion Criteria: * Postmenopausal women, aged ≥ 55 to ≤ 90. * Received oral bisphosphonate therapy for at least 3 years immediately prior to screening * BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck * History of nonvertebral fracture after age 50, or vertebral fracture. Exc...
Romozosumab is an investigational monoclonal antibody developed by Amgen Inc. (ticker AMGN) for the treatment of postmenopausal osteoporosis. It is in Phase 3 clinical development in the endocrine therapeutic area. It has been studied in postmenopausal women aged 55 years and older.
Romozosumab is being developed for postmenopausal osteoporosis, a condition of reduced bone mass in women after menopause. Its clinical program has evaluated it in postmenopausal women aged 55 years and older. It is investigational and has not been established as an approved therapy.
Romozosumab is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor of the clinical program studying the monoclonal antibody in postmenopausal osteoporosis.
Romozosumab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Its Phase 3 program in postmenopausal osteoporosis includes one completed trial, and no trials are currently active.
Romozosumab has been studied in the Phase 3 trial NCT01796301, titled an open-label study evaluating treatment with romozosumab or teriparatide in postmenopausal women. The trial enrolled 436 participants, was active-controlled, and has been completed. It was conducted in the United States, Argentina, Belgium, Canada, Colombia, Czechia, Denmark, Hungary, Poland, Spain, and the United Kingdom.
Yes, romozosumab is a monoclonal antibody. It is being developed by Amgen Inc. as an investigational therapy for postmenopausal osteoporosis and is in Phase 3 clinical development.