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

NCT00384358 | Completed Phase 2

• 2 other identifiers: 3100N7-211B1921004
• Study Type: interventional
• Target: 108
• Locations: 10 countries
• Sites: 30

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.

Conditions

Fractures

Keywords

Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

A

EXPERIMENTAL

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

Drug: rhBMP-2/CPM

B

EXPERIMENTAL

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

Drug: rhBMP-2/CPM

C

OTHER

Control: Surgical fixation

Other: surgical intervention alone

Interventions

rhBMP-2/CPM DRUG

one time injection of 3-5 mL test article at time of internal fracture fixation

A

surgical intervention alone OTHER

surgical internal fixation of fracture defines the standard of care group

C

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (30)

Pfizer Investigational Site

Aurora, Colorado, 80012, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33756, United States

Location

Pfizer Investigational Site

Pinellas Park, Florida, 33703, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

New Brunswick, New Jersey, 08903, United States

Location

Pfizer Investigational Site

Brooklyn, New York, 11220, United States

Location

Pfizer Investigational Site

Elmhurst, New York, 11373, United States

Location

Pfizer Investigational Site

Liverpool, New South Wales, 2170, Australia

Location

Pfizer Investigational Site

Herston, Queensland, 4029, Australia

Location

Pfizer Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Pfizer Investigational Site

Melbourne, Victoria, 3004, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3050, Australia

Location

Pfizer Investigational Site

Ajax, Ontario, L157J5, Canada

Location

Pfizer Investigational Site

Chatham, Ontario, N7M 5L9, Canada

Location

Pfizer Investigational Site

Scarborough Village, Ontario, M1E 4B9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

Pfizer Investigational Site

Oulu, 9002, Finland

Location

Pfizer Investigational Site

Turku, 20520, Finland

Location

Pfizer Investigational Site

Créteil, 94010, France

Location

Pfizer Investigational Site

Marseille, 13009, France

Location

Pfizer Investigational Site

Berlin, 13353, Germany

Location

Pfizer Investigational Site

Münster, 48149, Germany

Location

Pfizer Investigational Site

Budapest, H-1081, Hungary

Location

Pfizer Investigational Site

Debrecen, H-4043, Hungary

Location

Pfizer Investigational Site

Bergen, NO-5009, Norway

Location

Pfizer Investigational Site

Oslo, NO-0407, Norway

Location

Pfizer Investigational Site

Link?ping, SE-581 85, Sweden

Location

Pfizer Investigational Site

Edinburgh, EH16 4SA, United Kingdom

Location

Pfizer Investigational Site

Norwich, NR4 7UY, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fractures, Bone

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 6, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 28, 2013

Record last verified: 2013-02

Locations

HU (2); FR (2); AU (5); DE (2); US (8); GB (2); NO (2); SE (1); FI (2); CA (4)