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A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

Primary Purpose

Fractures

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
rhBMP-2/CPM
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures focused on measuring Fracture, Humerus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Other

Arm Label

A

B

C

D

Arm Description

1.0 mg/mL rhBMP-2/CPM + SOC

2.0 mg/mL rhBMP-2/CPM + SOC

Buffer/CPM + SOC

Standard of Care Alone (SOC)

Outcomes

Primary Outcome Measures

The primary efficacy variable in this study is radiographic union.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2006
Last Updated
February 21, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00384852
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
Fracture, Humerus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
1.0 mg/mL rhBMP-2/CPM + SOC
Arm Title
B
Arm Type
Experimental
Arm Description
2.0 mg/mL rhBMP-2/CPM + SOC
Arm Title
C
Arm Type
Active Comparator
Arm Description
Buffer/CPM + SOC
Arm Title
D
Arm Type
Other
Arm Description
Standard of Care Alone (SOC)
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Primary Outcome Measure Information:
Title
The primary efficacy variable in this study is radiographic union.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Brazil, xavierl@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Mexico, gomezzlj@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Sao Paulo
ZIP/Postal Code
04020-060
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
08270-070
Country
Brazil
City
São Paulo
ZIP/Postal Code
08270-070
Country
Brazil
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L157J5
Country
Canada
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 5L9
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
City
Charlottetown
ZIP/Postal Code
C1A8T5
Country
Canada
City
Oulu
ZIP/Postal Code
9002
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Angers
ZIP/Postal Code
49100
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Muenster
ZIP/Postal Code
48149
Country
Germany
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31020
Country
Mexico
City
D.f.
ZIP/Postal Code
11250
Country
Mexico
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway
City
Bucharest
ZIP/Postal Code
14461
Country
Romania
City
Bucharest
ZIP/Postal Code
21659
Country
Romania
City
Bucharest
ZIP/Postal Code
50098
Country
Romania
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35727196
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.
Results Reference
derived

Learn more about this trial

A Study of rhBMP-2/CPM in Closed Fractures of the Humerus

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