Closed Fractures of the Humerus MedDRA version: 8.1 Level: LLT Classification code 10017127 Term: Fracture of humerus
Conditions
Sponsors
Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects signed and dated IRB or IEC-approved informed consent form. 2. Skeletally mature and aged >= 18 years (closed epiphysis) 3. Subjects with a either a closed proximal humeral fracture or a diaphyseal humerus fracture classified as: - Proximal Humeral Fracture (NEER classification): nondisplaced, minimally displaced (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Open proximal or humeral shaft fractures. 2. Additional planned procedure(s) to stimulate fracture union following application of an initial immobilization device. 3. Shoulder dislocation at the time of injury. 4. Fractures located in the distal third of the humerus. 5. Concurrent fractures of the ipsilateral or contralateral upper extremity that would impede performance on a functional assessment. 6. Treatment initiated for osteoporosis within the past 16 weeks. 7. Any previous use of therapies that can be considered bone anabolic (parathyroid hormone, growth hormone, anabolic steroids or fluoride at bone therapeutic doses) within the past year. 8. Pathological fractures, except if due to postmenopausal or senile osteoporosis 9. Documented history of amlignacy, except basal or squalmous carinoma that has been treated and has fully resolved for a minimum of 5 years. 10.Retained surgical hardware in the humerous under study due to previous fracture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate that fracture union is accelerated in subjects with humeral fractures (proximal, shaft) treated with conservative (nonoperative) therapy SOC and a single dose of rhBMP-2/CPM (either 1.0 or 2.0 mg/mL) compared to subjects who are treated with SOC alone;Secondary Objective: 1. Demonstrate the safety of administering rhBMP-2/CPM in subjects with closed humeral fractures including key safety outcomes. 2. Demonstrate feasibility by establishing a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial for this clinical indication;Primary end point(s): The primary efficacy variable in this study is radiographic union. Radiographic fracture union was selected as a surrogate endpoint for this study because it is considered a strong predictor of fracture healing | — |
Countries
Finland, France, Sweden
Outcome results
None listed