drugset / Trial / NCT00787358

A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women

NCT00787358 ↗

Phase 2 Withdrawn 50 enrolled Zelos Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-12
Primary completion
2009-06
Completion
2009-07

Outcome

Outcome not reported

Stopped: “Change in company direction”

Drugs

EvaluationDrugModalityDoseRoute
Comparator OSTABOLIN-C Unknown 0.08 ml Subcutaneous

Indications