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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00384358
• Date of registration: 03/10/2006
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
• Scientific 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
• Date of first enrolment: December 2006
• Target sample size: 108
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00384358
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Fractures

Intervention(s)

Drug: rhBMP-2/CPM

Other: surgical intervention alone

Primary Outcome(s)

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]

Secondary Outcome(s)

To estimate the success and failure rates associated with key fracture outcomes. [Time Frame: 6 months follow-up]

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]

Secondary ID(s)

B1921004

3100N7-211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors