Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00384852




Registration number
NCT00384852
Ethics application status
Date submitted
3/10/2006
Date registered
6/10/2006
Date last updated
28/02/2013

Titles & IDs
Public title
A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
Scientific title
A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus
Secondary ID [1] 0 0
3100N7-212
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

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

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

Active Comparator: C - Buffer/CPM + SOC

Other: D - Standard of Care Alone (SOC)


Treatment: Drugs: rhBMP-2/CPM
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy variable in this study is radiographic union.
Timepoint [1] 0 0
Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.

Eligibility
Key inclusion criteria
- Skeletally mature subjects age 18 years or older.

- Subjects with either a closed proximal humeral fracture or a diaphyseal humeral
fracture.

- Treatment plan that includes only conservative (nonoperative) therapy within 48 hours
following injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Shoulder dislocation at the time of injury.

- Planned procedure(s) at that would stimulate fracture union at the time of application
of the initial immobilization device.

- Fractures located in the distal third of humerus.

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


The people analysing the results/data
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
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
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
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Charlottetown
Country [14] 0 0
Finland
State/province [14] 0 0
Oulu
Country [15] 0 0
Finland
State/province [15] 0 0
Turku
Country [16] 0 0
France
State/province [16] 0 0
Angers
Country [17] 0 0
France
State/province [17] 0 0
Creteil
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Muenster
Country [20] 0 0
Mexico
State/province [20] 0 0
Jalisco
Country [21] 0 0
Mexico
State/province [21] 0 0
Nuevo Leon
Country [22] 0 0
Mexico
State/province [22] 0 0
Chihuahua
Country [23] 0 0
Mexico
State/province [23] 0 0
D.f.
Country [24] 0 0
Norway
State/province [24] 0 0
Oslo
Country [25] 0 0
Romania
State/province [25] 0 0
Bucharest
Country [26] 0 0
Sweden
State/province [26] 0 0
Linköping

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 whether fracture union is accelerated in
subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy
(standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard
of care alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00384852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of 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/ct2/show/NCT00384852