Fractures
Conditions
Keywords
Fracture, Humerus
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.
Interventions
DRUGrhBMP-2/CPM
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
Australia, Brazil, Canada, Finland, France, Germany, Mexico, Norway, Romania, Sweden, United States
Outcome results
None listed