NCT00384358

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	rhBMP-2/CPM	one time injection of 3-5 mL test article at time of internal fracture fixation
DRUG	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

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-10-06
• Last updated: 2013-02-28

Locations

30 sites across 10 countries: United States, Australia, Canada, Finland, France, Germany, Hungary, Norway, Sweden, United Kingdom