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Completed

NCT Number: NCT00384358

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

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhBMP-2/CPM

Drug

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

surgical intervention alone

Other

surgical internal fixation of fracture defines the standard of care group

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.

    Time frame: upon completion 6 months of follow-up

Secondary outcomes

  1. 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

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

    Time frame: 6 months follow-up

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 6, 2006
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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