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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02578095 | Acute Hip Fracture Study in Patients 65 Years or Greater | PHASE2 | COMPLETED | 108 | — | — | Oct 30, 2015 | Dec 17, 2017 | Dec 29, 2025 | 21 | United States, Hungary +2 |
Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo QD |
| VK5211- 0.5mg | EXPERIMENTAL | 0.5mgQD |
| VK5211- 1.0mg | EXPERIMENTAL | 1.0mg QD |
| VK5211- 2.0mg | EXPERIMENTAL | 2.0mg QD |
| Name | Type | Description |
|---|---|---|
| VK5211 | DRUG | Capsule |
| Placebo | DRUG | Capsule |
Inclusion Criteria: * Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation. Exclusion Criteria: * Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 23 | NA | Undisclosed |
| Stryker Corporation | SYK | 4 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | NA | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | — | Undisclosed |
| Cooper Companies, Inc. | COO | 1 | — | Undisclosed |