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

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.

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Key information

Conditions

Fractures Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Herston, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhBMP-2/CPM

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Oct 6, 2006
Registry last updated: Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed