NCT00384852

A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

Conditions

• Fractures

Interventions

Type	Name	Description
DRUG	rhBMP-2/CPM

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2006-10-06
• Last updated: 2013-02-28

Locations

37 sites across 11 countries: United States, Australia, Brazil, Canada, Finland, France, Germany, Mexico, Norway, Romania, Sweden