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

Primary Purpose

Fractures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rhBMP-2/CPM
rhBMP-2/CPM
surgical intervention alone
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures focused on measuring Fractures

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

A

B

C

Arm Description

1.0 mg/mL rhBMP-2/CPM + surgical fixation

2.0 mg/mL rhBMP-2/CPM + surgical fixation

Control: Surgical fixation

Outcomes

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.

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.
To estimate the success and failure rates associated with key fracture outcomes.

Full Information

First Posted
October 3, 2006
Last Updated
February 21, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00384358
Brief Title
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
1.0 mg/mL rhBMP-2/CPM + surgical fixation
Arm Title
B
Arm Type
Experimental
Arm Description
2.0 mg/mL rhBMP-2/CPM + surgical fixation
Arm Title
C
Arm Type
Other
Arm Description
Control: Surgical fixation
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Intervention Description
one time injection of 3-5 mL test article at time of internal fracture fixation
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Intervention Description
one time injection of 3-5 mL test article at time of internal fracture fixation
Intervention Type
Other
Intervention Name(s)
surgical intervention alone
Intervention Description
surgical internal fixation of fracture defines the standard of care group
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To estimate the success and failure rates associated with key fracture outcomes.
Time Frame
6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Pfizer Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Pfizer Investigational Site
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Pfizer Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Pfizer Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Pfizer Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L157J5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 5L9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
9002
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1081
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
H-4043
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Bergen
ZIP/Postal Code
NO-5009
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway
Facility Name
Pfizer Investigational Site
City
Link?ping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3100N7-211&StudyName=Feasibility%20And%20Safety%20Study%20Of%20rhBMP-2/CPM%20For%20Hip%20Fractures
Description
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Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

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