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

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. Neurovascular impairment in the region under study.
7. Documented history of heterotopic ossification.
8. Documented active infection in any anatomical location.
9. Retained surgical hardware in the humerus under study due to previous fracture.
10. Pathological fractures, except if due to postmenopausal or senile osteoporosis.
11. Treatment initiated for osteoporosis within the past 16 weeks.
12. 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.
13. History of other metabolic bone disorders that may affect the region under study (eg, Paget's disease, renal osteodystrophy, or benign tumor).
14. Documented history of malignancy, except basal or squamous cell carcinoma that has been treated and has fully resolved for a minimum of 5 years.
15. History of hypersensivity to rhBMP-2 or to protein pharmaceuticals (such as monoclonal antibodies or gamma globulins).
16. Treatment with any investigational therapy within the past 30 days.
17. Documented history of ongoing alcohol or drug addiction.
18. Any other concurrent condition(s) that, in the judgement of the investigator, would prohibit the subject from participating in the study or hinder the collection of data and interpretation of results (eg, unstable medical condition, life expectancy less than 1 year or inability to comply with required follow-up evaluations).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials