Feasibility and Safety Study of rhBMP-2/CPM for Fractures of the Proximal Femur - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384358

Purpose

The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

Condition	Intervention	Phase
Fractures	Drug: rhBMP-2/CPM	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone. [ Time Frame: Safety will be established if, upon completion of the first 6 months of follow-up, key safety outcomes in the active treatment groups are comparable in clinical characteristic and severity to those of the sOC control group ] [ Designated as safety issue: Yes ]

Enrollment:	108
Study Start Date:	November 2006
Estimated Study Completion Date:	February 2011
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 1.0 mg/mL rhBMP-2/CPM + surgical fixation	Drug: rhBMP-2/CPM
B: Experimental 2.0 mg/mL rhBMP-2/CPM + surgical fixation	Drug: rhBMP-2/CPM
C Control: Surgical fixation	Drug: rhBMP-2/CPM

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 55 or older.
Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
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.

Exclusion Criteria:

Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
Previous arthroplasty of contralateral (unaffected) hip.
Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384358

Show 30 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3100N7-211
Study First Received:	October 3, 2006
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00384358 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Fractures

Study placed in the following topic categories:

Fractures, Bone
Adjuvants, Immunologic
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on September 03, 2009