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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384358
First received: October 3, 2006
Last updated: February 21, 2013
Last verified: February 2013
  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
Other: surgical intervention alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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: upon completion 6 months of follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To estimate the success and failure rates associated with key fracture outcomes. [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: December 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
C
Control: Surgical fixation
Other: surgical intervention alone
surgical internal fixation of fracture defines the standard of care group

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 30 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00384358     History of Changes
Other Study ID Numbers: 3100N7-211, B1921004
Study First Received: October 3, 2006
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Fractures

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014