Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384358

Enrollment

108

Registered

2006-10-06

Start date

2006-12-31

Completion date

2010-06-30

Last updated

2013-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures

Keywords

Fractures

Brief summary

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.

Interventions

DRUGrhBMP-2/CPM

one time injection of 3-5 mL test article at time of internal fracture fixation

OTHERsurgical intervention alone

surgical internal fixation of fracture defines the standard of care group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	upon completion 6 months of follow-up

Secondary

Measure	Time frame
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.	6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.	6 months follow-up

Countries

Australia, Canada, Finland, France, Germany, Hungary, Norway, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026