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Label indication EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. FDA label
Also known as Evenity, AMG785
romosozumab HCP administration with PFS · 1 trial · 1 indication
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
| Arm | Type | Description |
|---|---|---|
| Romosozumab 210 mg QM: PFS | ACTIVE_COMPARATOR | During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS. |
| Romosozumab 210 mg QM: AI/Pen | ACTIVE_COMPARATOR | During the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen. |
| Name | Type | Description |
|---|---|---|
| romosozumab HCP administration with PFS | DRUG | 210 mg romosozumab SC QM by HCP administration with 2 PFS |
| romosozumab self-administration with AI/Pen | DEVICE | 210 mg romosozumab SC QM by self-administration with 2 AI/Pens |
Inclusion Criteria: * Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any ...
Romosozumab HCP administration with PFS is being studied for post-menopausal osteoporosis, a condition of reduced bone mass in women after menopause. The Phase 3 trial NCT03432533 compared healthcare provider-administered romosozumab with subject-administered romosozumab in this indication.
Romosozumab HCP administration with PFS targets sclerostin, encoded by the SOST gene. It is a monoclonal antibody that acts as an inhibitor of sclerostin. By binding sclerostin, it affects bone metabolism, which is relevant in post-menopausal osteoporosis.
Romosozumab HCP administration with PFS is being developed by Amgen Inc., which trades under the ticker AMGN. The company is responsible for the clinical development of this monoclonal antibody for post-menopausal osteoporosis.
Romosozumab HCP administration with PFS is in Phase 3 clinical development. The single listed trial, NCT03432533, is a completed Phase 3 study. The drug is investigational and has not been approved by the FDA for this administration method.
Romosozumab HCP administration with PFS has been evaluated in one Phase 3 clinical trial, NCT03432533, titled 'A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis.' This completed trial enrolled 283 female participants aged 55 years and older in the United States, Poland, and the United Kingdom.