Clinical trial NCT00384852: A Study of rhBMP-2/CPM in Closed Fractures of the Humerus
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fractures
Keywords: Fracture
Humerus
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy variable in this study is radiographic union.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Brooklyn
country: United States
state: New York
city: Monroe
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: State College
country: United States
state: Pennsylvania
city: Herston
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
city: Vancouver
country: Canada
state: British Columbia
city: Ajax
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Charlottetown
country: Canada
city: Oulu
country: Finland
city: Turku
country: Finland
city: Angers
country: France
city: Creteil
country: France
city: Berlin
country: Germany
city: Muenster
country: Germany
city: Guadalajara
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Chihuahua
country: Mexico
city: D.f.
country: Mexico
city: Oslo
country: Norway
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Linköping
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezzlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.