Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00161629

Purpose

To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

Condition	Intervention	Phase
Radius Fractures	Drug: rhBMP-2/CPM	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.

Secondary Outcome Measures:

Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.

Estimated Enrollment:	40
Study Start Date:	September 2005
Study Completion Date:	January 2007

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures.
Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study.

Other inclusion applies.

Exclusion Criteria:

Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit).
Fracture fixation by other means (eg, plate and screw fixation).
Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated.

Other exclusion applies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161629

Locations

Finland

Turku, Finland, 20520

Kuopio, Finland, 70211

Oulu, Finland, 70211
France

Paris, France, 75970

Paris, France, 75651

Paris, France, 75012

Creteil, France, 94010

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Finland, MedInfoNord@wyeth.com

More Information

No publications provided

Study ID Numbers:	3100N7-114
Study First Received:	September 1, 2005
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00161629 History of Changes
Health Authority:	Finland: Ethics Committee; France: Ministry of Health

Keywords provided by Wyeth:

Distal Radius Fractures

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on November 30, 2009