This is a 24-month, phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:
- A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
- A 6-month double-blind treatment period (teriparatide 20 µg or placebo given once daily by subcutaneous injection)
- An 18-month observation period.
The primary objective is to determine the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the percentage of participants with successful fracture healing 24 months after internal fixation of a low-trauma femoral neck fracture (after 12 months for non-US regions).
All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 24 months.