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

Phase 2

Completed

• Conditions: Fractures
• Interventions: Drug: rhBMP-2/CPM

• Registration Number: NCT00384852
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-06
• Study Start: 2007-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-21
• Disposition First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Disposition First Posted: 2013-02-28
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D	rhBMP-2/CPM	Standard of Care Alone (SOC)
B	rhBMP-2/CPM	2.0 mg/mL rhBMP-2/CPM + SOC
A	rhBMP-2/CPM	1.0 mg/mL rhBMP-2/CPM + SOC
C	rhBMP-2/CPM	Buffer/CPM + SOC

Primary Outcome Measures

Name	Time	Method
The primary efficacy variable in this study is radiographic union.	Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.