A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
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
1 other identifier
interventional
139
11 countries
37
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2007
Typical duration for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFebruary 28, 2013
February 1, 2013
3.1 years
October 3, 2006
February 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy variable in this study is radiographic union.
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.
Study Arms (4)
A
EXPERIMENTAL1.0 mg/mL rhBMP-2/CPM + SOC
B
EXPERIMENTAL2.0 mg/mL rhBMP-2/CPM + SOC
C
ACTIVE COMPARATORBuffer/CPM + SOC
D
OTHERStandard of Care Alone (SOC)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Aurora, Colorado, 80012, United States
Unknown Facility
Denver, Colorado, 80204, United States
Unknown Facility
Clearwater, Florida, 33756, United States
Unknown Facility
St. Petersburg, Florida, 33781, United States
Unknown Facility
Brooklyn, New York, 11220, United States
Unknown Facility
Monroe, North Carolina, 28112, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Unknown Facility
State College, Pennsylvania, 16801, United States
Unknown Facility
Herston, Queensland, 4029, Australia
Unknown Facility
Adelaide, South Australia, 5000, Australia
Unknown Facility
Melbourne, Victoria, 3004, Australia
Unknown Facility
São Paulo, São Paulo, 04020-060, Brazil
Unknown Facility
São Paulo, São Paulo, 08270-070, Brazil
Unknown Facility
Vancouver, British Columbia, V6Z 1Y6, Canada
Unknown Facility
Ajax, Ontario, L157J5, Canada
Unknown Facility
Chatham, Ontario, N7M 5L9, Canada
Unknown Facility
Oshawa, Ontario, L1G 2B9, Canada
Unknown Facility
Scarborough Village, Ontario, M1E 4B9, Canada
Unknown Facility
Windsor, Ontario, N9A 1E1, Canada
Unknown Facility
Montreal, Quebec, H4J 1C5, Canada
Unknown Facility
Charlottetown, C1A8T5, Canada
Unknown Facility
Oulu, 9002, Finland
Unknown Facility
Turku, 20520, Finland
Unknown Facility
Angers, 49100, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Münster, 48149, Germany
Unknown Facility
Chihuahua City, Chihuahua, 31020, Mexico
Unknown Facility
Guadalajara, Jalisco, 44280, Mexico
Unknown Facility
Monterrey, Nuevo León, 64460, Mexico
Unknown Facility
D.f., 11250, Mexico
Unknown Facility
Oslo, NO-0407, Norway
Unknown Facility
Bucharest, 14461, Romania
Unknown Facility
Bucharest, 21659, Romania
Unknown Facility
Bucharest, 50098, Romania
Unknown Facility
Linköping, SE-581 85, Sweden
Related Publications (1)
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PMID: 35727196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Brazil, xavierl@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Mexico, gomezzlj@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2006
First Posted
October 6, 2006
Study Start
January 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 28, 2013
Record last verified: 2013-02