Unstable Intertrochanteric Fracture Clinical Trial
Official title:
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)
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.
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.
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