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

February 21, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Pfizer Investigational Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Pfizer Investigational Site
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L157J5
        • Pfizer Investigational Site
      • Chatham, Ontario, Canada, N7M 5L9
        • Pfizer Investigational Site
      • Scarborough, Ontario, Canada, M1E 4B9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Pfizer Investigational Site
  • Finland
      • Oulu, Finland, 9002
        • Pfizer Investigational Site
      • Turku, Finland, 20520
        • Pfizer Investigational Site
  • France
      • Creteil, France, 94010
        • Pfizer Investigational Site
      • Marseille, France, 13009
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Pfizer Investigational Site
      • Muenster, Germany, 48149
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, H-1081
        • Pfizer Investigational Site
      • Debrecen, Hungary, H-4043
        • Pfizer Investigational Site
  • Norway
      • Bergen, Norway, NO-5009
        • Pfizer Investigational Site
      • Oslo, Norway, NO-0407
        • Pfizer Investigational Site
  • Sweden
      • Link?ping, Sweden, SE-581 85
        • Pfizer Investigational Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SA
        • Pfizer Investigational Site
      • Norwich, United Kingdom, NR4 7UY
        • Pfizer Investigational Site
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Pfizer Investigational Site
      • Pinellas Park, Florida, United States, 33703
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11220
        • Pfizer Investigational Site
      • Elmhurst, New York, United States, 11373
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 55 or older.
  • Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
  • Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.

Exclusion Criteria:

  • Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
  • Previous arthroplasty of contralateral (unaffected) hip.
  • Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation
Experimental: B
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation
Other: C
Control: Surgical fixation
Other: surgical intervention alone
surgical internal fixation of fracture defines the standard of care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
Time Frame: upon completion 6 months of follow-up
upon completion 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
Time Frame: 6 months follow-up
6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.
Time Frame: 6 months follow-up
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3100N7-211
  • B1921004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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