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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01473589 | Effect of Teriparatide on Hip Fracture Healing | PHASE3 | COMPLETED | 122 | — | — | Feb 1, 2012 | Dec 1, 2013 | Apr 16, 2015 | 92 | United States, Australia +17 |
| NCT01473602 | Second Study of the Effect of Teriparatide on Hip Fracture Healing | PHASE3 | COMPLETED | 39 | — | — | Jan 1, 2012 | Nov 1, 2013 | Apr 16, 2015 | 75 | United States, Belgium +12 |
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Administered once daily by subcutaneous (SC) injection for 6 months |
| Teriparatide | EXPERIMENTAL | 20 microgram (µg) administered once daily by SC injection for 6 months |
| Name | Type | Description |
|---|---|---|
| Teriparatide | DRUG | Administered by SC injection |
| Placebo | DRUG | Administered by SC injection |
| Calcium supplementation | DIETARY_SUPPLEMENT | Administered orally |
| Vitamin D supplementation | DIETARY_SUPPLEMENT | Administered orally |
Inclusion Criteria: * Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced) * Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 ye...