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

Wyeth

Status and phase: Completed; Phase 2

Conditions: Fractures

Treatments: Drug: rhBMP-2/CPM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384852

3100N7-212

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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139 participants in 4 patient groups

A

Experimental group

Description:

1.0 mg/mL rhBMP-2/CPM + SOC

Treatment:

Drug: rhBMP-2/CPM

B

Experimental group

Description:

2.0 mg/mL rhBMP-2/CPM + SOC

Treatment:

Drug: rhBMP-2/CPM

C

Active Comparator group

Description:

Buffer/CPM + SOC

Treatment:

Drug: rhBMP-2/CPM

D

Other group

Description:

Standard of Care Alone (SOC)

Treatment:

Drug: rhBMP-2/CPM