MedTrace Logo

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

NCT00787358 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-06-04

No results posted yet for this study

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.

Conditions

  • Hip Fracture

Interventions

DRUG

ZT-031

80 ul subcutaneous injection per day

OTHER

placebo

80 ul daily subcutaneous injection of vehicle only

Sponsors & Collaborators

  • Zelos Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787358 on ClinicalTrials.gov