A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur

• Conditions: Closed fracture of the proximal femur; MedDRA version: 8.1Level: LLTClassification code 10020100Term: Hip fracture

• Registration Number: EUCTR2006-001832-34-SE
• Lead Sponsor: Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

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

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 that has been fully resolved for a minimum of 5 years.
10. Retained surgical hardware in the femur under study due to previous fracture.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified