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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Criteria

Inclusion Criteria:

• Skeletally mature subjects age 18 years or older.

• Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.

• Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.

Exclusion Criteria:

• Shoulder dislocation at the time of injury.

• Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.

• Fractures located in the distal third of humerus.