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
Overview
- Phase
- Phase 2
- Intervention
- rhBMP-2/CPM
- Conditions
- Fractures
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 139
- Primary Endpoint
- The primary efficacy variable in this study is radiographic union.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
A
1.0 mg/mL rhBMP-2/CPM + SOC
Intervention: rhBMP-2/CPM
B
2.0 mg/mL rhBMP-2/CPM + SOC
Intervention: rhBMP-2/CPM
C
Buffer/CPM + SOC
Intervention: rhBMP-2/CPM
D
Standard of Care Alone (SOC)
Intervention: rhBMP-2/CPM
Outcomes
Primary Outcomes
The primary efficacy variable in this study is radiographic union.
Time Frame: 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.