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Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

NCT00384358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2013-02-28

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

Conditions

  • Fractures

Interventions

DRUG

rhBMP-2/CPM

one time injection of 3-5 mL test article at time of internal fracture fixation

DRUG

rhBMP-2/CPM

one time injection of 3-5 mL test article at time of internal fracture fixation

OTHER

surgical intervention alone

surgical internal fixation of fracture defines the standard of care group

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • France
  • Germany
  • Hungary
  • Norway
  • Sweden
  • United Kingdom

Study Locations

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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 NCT00384358 on ClinicalTrials.gov