NCT01473589

Effect of Teriparatide on Hip Fracture Healing

Effect of Teriparatide on Femoral Neck Fracture Healing

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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 \[teriparatide 20 µg or placebo given once daily by SC injection\] 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.

Conditions

• Femur Neck Fracture

Interventions

Type	Name	Description
DRUG	Teriparatide	Administered by SC injection
DRUG	Placebo	Administered by SC injection
DIETARY_SUPPLEMENT	Calcium supplementation	Administered orally
DIETARY_SUPPLEMENT	Vitamin D supplementation	Administered orally

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-11-17
• Last updated: 2015-04-16
• Results posted: 2014-11-17

Locations

92 sites across 19 countries: United States, Australia, Canada, Denmark, Estonia, Finland, Hong Kong, India, Israel, Japan, Latvia, Lithuania, New Zealand, Norway, Puerto Rico, South Korea, Spain, Sweden, Taiwan