Clinical Trial: Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an

Brief Summary: To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.

Original Primary Outcome: Same as current

Current Secondary Outcome: Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 1, 2005
Date Started: September 2005
Date Completion:
Last Updated: December 3, 2007
Last Verified: December 2007