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

Wyeth Pharmaceuticals Inc.0 个研究点目标入组 132 人开始时间: 2006年11月30日最近更新: 2021年10月8日

试验速览

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•1. Subjects signed and dated IRB or IEC-approved informed consent form.
•2. Skeletally mature and aged >= 18 years
•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

•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

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