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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)
Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)
1000 mg/day of elemental calcium
Faculty of Medicine Chulalongkorn University
Bangkok, Thailand
Time to healing assessed by radiographic evidence
Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices)
Time frame: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes
Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, \<70 poor)
Time frame: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes
Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing)
Time frame: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by walking ability as one of functional outcomes
Walking ability (Independent walking, Assisted walking, Bedridden)
Time frame: from randomization, assessed up to 24 months
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20,000 IU/week of vitamin D2