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

Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384852
• Other study ID #: 3100N7-212
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2006
• Last updated: February 21, 2013
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures
• Fractures, Bone
• Fractures, Closed

Intervention

Drug:
• rhBMP-2/CPM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Finland,  France,  Germany,  Mexico,  Norway,  Romania,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No