Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for post-menopausal osteoporosis. It is being studied in a Phase 3 clinical trial that compares subject-administered romosozumab with healthcare provider-administered romosozumab for osteoporosis. The trial is completed and enrolled 283 female participants aged 55 years and older.
Romosozumab HCP administration with PFS is developed by Amgen Inc., which trades under the ticker AMGN. The company conducted a Phase 3 clinical trial to evaluate this drug for post-menopausal osteoporosis.
Romosozumab HCP administration with PFS is in Phase 3 clinical development. The Phase 3 trial, NCT03432533, has been completed. It is an investigational drug and is not approved for use.
Romosozumab HCP administration with PFS has one completed Phase 3 trial, NCT03432533, titled 'A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis.' The trial enrolled 283 participants with post-menopausal osteoporosis in the United States, Poland, and the United Kingdom.
Romosozumab HCP administration with PFS refers to a specific administration method of romosozumab, where the drug is given by a healthcare provider using a prefilled syringe. The clinical trial compares this method with subject-administered romosozumab for post-menopausal osteoporosis.