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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00384358
Ethics application status
Date submitted
3/10/2006
Date registered
3/10/2006
Date last updated
21/02/2013

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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