Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03432533 | A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis | PHASE3 | COMPLETED | 283 | — | — | Feb 6, 2018 | Jan 8, 2020 | Nov 23, 2020 | 46 | United States, Poland +1 |
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 ...