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A Phase 2, Multicenter, Feasibility and Safety Study of rhBMP-2/CPM for Fractures of the Proximal Femur

This study is currently recruiting participants.
Verified by Wyeth, October 2008

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00384358
  Purpose

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.


Condition Intervention Phase
Fractures
Drug: rhBMP-2/CPM
Phase II

MedlinePlus related topics:   Fractures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Official Title:   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

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • 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: Safety will be established if, upon completion of the first 6 months of follow-up, key safety outcomes in the active treatment groups are comparable in clinical characteristic and severity to those of the sOC control group ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   108
Study Start Date:   November 2006
Estimated Study Completion Date:   February 2010
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
B: Experimental
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Drug: rhBMP-2/CPM
C
Control: Surgical fixation
Drug: rhBMP-2/CPM

  Eligibility
Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384358

Contacts
Contact: Trial Manager     clintrialparticipation@wyeth.com    

Show 30 study locations  Show 30 Study Locations

Sponsors and Collaborators
Wyeth

Investigators
Study Director:     Medical Monitor     Wyeth    
  More Information


Responsible Party:   Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:   3100N7-211
First Received:   October 3, 2006
Last Updated:   October 21, 2008
ClinicalTrials.gov Identifier:   NCT00384358
Health Authority:   United States: Food and Drug Administration

Keywords provided by Wyeth:
Fractures  

Study placed in the following topic categories:
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 29, 2008




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