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

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ClinicalTrials.gov Identifier: NCT00384852
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Fractures Drug: rhBMP-2/CPM Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: A
1.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Experimental: B
2.0 mg/mL rhBMP-2/CPM + SOC
Drug: rhBMP-2/CPM
Active Comparator: C
Buffer/CPM + SOC
Drug: rhBMP-2/CPM
D
Standard of Care Alone (SOC)
Drug: rhBMP-2/CPM



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384852


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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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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

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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00384852     History of Changes
Other Study ID Numbers: 3100N7-212
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Fracture
Humerus

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries