Femur Neck Fracture Clinical Trial
Official title:
Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing
The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).
This is a 12-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:
1. A screening period that must be completed in ≤ 14 days after operative treatment of the
femoral neck fracture
2. A 6-month double-blind treatment period [teriparatide 20 (µg) or placebo given once
daily by subcutaneous injection]
3. A 6-month observation period.
The primary objective is to assess the effect of 6 months of treatment with teriparatide 20
µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years
of age with no revision surgery 12 months after internal fixation of a low-trauma femoral
neck fracture.
All participants will receive supplements of calcium and vitamin D beginning at screening
and continuing for 12 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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