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NCT00384358 Clinical Trial

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

Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00384358
Other study ID # 3100N7-211
Secondary ID B1921004
Status Completed
Phase Phase 2
First received October 3, 2006
Last updated February 21, 2013
Start date December 2006
Est. completion date June 2010

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation
• rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation
Other:
• surgical intervention alone
surgical internal fixation of fracture defines the standard of care group

Locations
Country Name City State
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Herston Queensland
Australia Pfizer Investigational Site Liverpool New South Wales
Australia Pfizer Investigational Site Melbourne Victoria
Australia Pfizer Investigational Site Parkville Victoria
Canada Pfizer Investigational Site Ajax Ontario
Canada Pfizer Investigational Site Chatham Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Scarborough Ontario
Finland Pfizer Investigational Site Oulu
Finland Pfizer Investigational Site Turku
France Pfizer Investigational Site Creteil
France Pfizer Investigational Site Marseille
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Muenster
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Debrecen
Norway Pfizer Investigational Site Bergen
Norway Pfizer Investigational Site Oslo
Sweden Pfizer Investigational Site Link?ping
United Kingdom Pfizer Investigational Site Edinburgh
United Kingdom Pfizer Investigational Site Norwich
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site Decatur Georgia
United States Pfizer Investigational Site Elmhurst New York
United States Pfizer Investigational Site New Brunswick New Jersey
United States Pfizer Investigational Site New Haven Connecticut
United States Pfizer Investigational Site Pinellas Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 No
Secondary To estimate the success and failure rates associated with key fracture outcomes. 6 months follow-up No
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