Closed fracture of the proximal femur MedDRA version: 8.1 Level: LLT Classification code 10020100 Term: Hip fracture
Conditions
Interventions
Product Name: DIBOTERMIN ALPHA(rhBMP-2)/CPM KIT
Product Code: DIBOTERMIN ALPHA(rhBMP-2)/CPM KIT
Pharmaceutical Form: Injection*
INN or Proposed INN: DIB
Sponsors
Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s signed and dated informed consent form, approved by the institutional review board (IRB) or independent ethics committee (IEC). 2. Age =55 years. 3. Acute closed fracture of the proximal femur: displaced femoral neck fracture (Garden Type III or IV); basilar neck fracture (Orthopaedic Trauma Association [OTA] Classification 31-B2); or unstable intertrochanteric femur fracture (OTA Classification 31-A2 or 31-A3) 4. Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail. 5. Domestically independent (noninstitutionalized) and ambulatory (with or without walking aids) before injury. 6. Score =21 on Mini-Mental State Examination, indicating that subject is cognitively intact. 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
Exclusion criteria: 1. Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments. 2. Previous arthroplasty of contralateral hip. 3. Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip. 4. Documented history of heterotopic ossification. 5. Pathological fractures, except if due to postmenopausal or senile osteoporosis. 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. History of other metabolic bone disorders that may affect the region under study (eg, Paget’s disease, renal osteodystrophy, or benign tumor). 9. Documented history of malignancy, except basal or squamous cell carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the safety of administering rhBMP-2/CPM (either 1.0 mg/mL or 2.0 mg/mL) as an adjunct to internal fixation in subjects with fractures of the proximal femur. The key safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM and those receiving standard surgical treatment (internal fixation) alone. ; Secondary Objective: To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication· To estimate the success and failure rates associated with key fracture outcomes ;Primary end point(s): The efficacy data for the trial stem from clinical, radiographic, and functional assesments aimed at evaluating the key fracture outcomes of fracture healing and restoration of functional mobility. Fracture healing is determined from a combined set of clinical and radiographic criteria: absence of pain with full weight bearing and presence of radiographic fracture union. Restauration of functional mobility is assessesd by subjects' performance on the timed up and go (TUG) test, a validated method closely associated with subjects' level of independence in basic mobility | — |
Countries
Finland, France, Germany, Hungary, Sweden, United Kingdom
Outcome results
None listed