Trials / Completed
CompletedNCT03133195
The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA
A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With Proximal Femoral Nail Antirotation (PFNA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- King Chulalongkorn Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
Detailed description
Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks. All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2. Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teriparatide | Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector) |
| DRUG | Placebo | Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector) |
| DIETARY_SUPPLEMENT | Calcium supplement | 1000 mg/day of elemental calcium |
| DIETARY_SUPPLEMENT | Vitamin D | 20,000 IU/week of vitamin D2 |
Timeline
- Start date
- 2017-05-17
- Primary completion
- 2022-06-01
- Completion
- 2023-07-01
- First posted
- 2017-04-28
- Last updated
- 2025-01-15
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT03133195. Inclusion in this directory is not an endorsement.