A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
- Registration Number
- NCT00787358
- Lead Sponsor
- Zelos Therapeutics
- Brief Summary
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following surgery and to determine if ZT-031 is safe for patients with fractures. To be allowed in the study you have to have a type of hip fracture that requires surgery that is being studied (intertrochanteric fracture). You must also otherwise be in good health, with no serious diseases such as cancer, neurologic disease, other bone disease, liver, heart or kidney disease. You must be able to inject yourself every day with the study medication using an injection pen, like that used for insulin injections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - ZT-031 ZT-031 -
- Primary Outcome Measures
Name Time Method Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16 16 weeks
- Secondary Outcome Measures
Name Time Method Screw barrel impaction distance 16 weeks Screw cut-out and/or other hardware failure 16 weeks Incidence of fracture non-union 16 weeks Need for surgical revision with or without hardware removal 16 weeks
Trial Locations
- Locations (1)
J. Edward Puzas
🇺🇸Rochester, New York, United States