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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00384358




Registration number
NCT00384358
Ethics application status
Date submitted
3/10/2006
Date registered
6/10/2006
Date last updated
28/02/2013

Titles & IDs
Public title
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
Scientific 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
Secondary ID [1] 0 0
B1921004
Secondary ID [2] 0 0
3100N7-211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rhBMP-2/CPM
Treatment: Drugs - rhBMP-2/CPM
Other interventions - surgical intervention alone

Experimental: A - 1.0 mg/mL rhBMP-2/CPM + surgical fixation

Experimental: B - 2.0 mg/mL rhBMP-2/CPM + surgical fixation

Other: C - Control: Surgical fixation


Treatment: Drugs: rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation

Treatment: Drugs: rhBMP-2/CPM
one time injection of 3-5 mL test article at time of internal fracture fixation

Other interventions: surgical intervention alone
surgical internal fixation of fracture defines the standard of care group
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
upon completion 6 months of follow-up
Secondary outcome [1] 0 0
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
Timepoint [1] 0 0
6 months follow-up
Secondary outcome [2] 0 0
To estimate the success and failure rates associated with key fracture outcomes.
Timepoint [2] 0 0
6 months follow-up

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Liverpool
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Finland
State/province [9] 0 0
Oulu
Country [10] 0 0
Finland
State/province [10] 0 0
Turku
Country [11] 0 0
France
State/province [11] 0 0
Creteil
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Muenster
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Debrecen
Country [17] 0 0
Norway
State/province [17] 0 0
Bergen
Country [18] 0 0
Norway
State/province [18] 0 0
Oslo
Country [19] 0 0
Sweden
State/province [19] 0 0
Link?ping
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Edinburgh
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00384358
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00384358