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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02186171 | A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis | PHASE3 | COMPLETED | 245 | — | — | Jun 16, 2014 | Apr 20, 2016 | May 28, 2019 | 34 | United States, Belgium +8 |
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
| Arm | Type | Description |
|---|---|---|
| Romosozumab | EXPERIMENTAL | Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injections once a month for 12 months. |
| Name | Type | Description |
|---|---|---|
| Romosozumab | BIOLOGICAL | Administered by subcutaneous injection once a month. |
| Placebo | DRUG | Administered by subcutaneous injection once a month. |
Inclusion Criteria: * Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age * Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture. Exclusion Criteria: * A BMD T score ≤ -3...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | NA | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | — | Undisclosed |