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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01796301 | An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women | PHASE3 | COMPLETED | 436 | — | — | Jan 31, 2013 | May 14, 2015 | Nov 29, 2022 | 50 | United States, Argentina +9 |
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...