A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus

Conditions: Closed Fractures of the Humerus
MedDRA version: 8.1Level: LLTClassification code 10017127Term: Fracture of humerus

Registration Number: EUCTR2006-001916-54-SE

Lead Sponsor: Wyeth Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 132

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 (<45° angluation and <1cm displaced), 2-Part, 3-Part or 4-Part
- Diaphyseal Humeral Fracture (OTA classification): Simple OTA 12-A- Wedge OTA 12-B or Complexe OTA 12-C
4. Treatment plan includes only conservative (non-operative) therapy within 48 hours of injury.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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

Secondary Outcome Measures