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

Phase 2

Completed

• Conditions: Fractures
• Interventions: Drug: rhBMP-2/CPM; Other: surgical intervention alone

• Registration Number: NCT00384358
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-06
• Study Start: 2006-12
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-21
• Disposition First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Disposition First Posted: 2013-02-28
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	rhBMP-2/CPM	1.0 mg/mL rhBMP-2/CPM + surgical fixation
B	rhBMP-2/CPM	2.0 mg/mL rhBMP-2/CPM + surgical fixation
C	surgical intervention alone	Control: Surgical fixation

Primary Outcome Measures

Name	Time	Method
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.	upon completion 6 months of follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Norwich, United Kingdom