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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80012 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00384358
Pfizer
Completed
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

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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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Fractures
  • Drug: rhBMP-2/CPM
    one time injection of 3-5 mL test article at time of internal fracture fixation
  • Other: surgical intervention alone
    surgical internal fixation of fracture defines the standard of care group
  • Experimental: A
    1.0 mg/mL rhBMP-2/CPM + surgical fixation
    Intervention: Drug: rhBMP-2/CPM
  • Experimental: B
    2.0 mg/mL rhBMP-2/CPM + surgical fixation
    Intervention: Drug: rhBMP-2/CPM
  • C
    Control: Surgical fixation
    Intervention: Other: surgical intervention alone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Finland,   France,   Germany,   Hungary,   Norway,   Sweden,   United Kingdom,   United States
 
 
NCT00384358
3100N7-211
B1921004
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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