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

Primary Purpose

Radius Fractures

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rhBMP-2/CPM
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Distal Radius Fractures

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

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.

Full Information

First Posted
September 1, 2005
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00161629
Brief Title
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
Keywords
Distal Radius Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Primary Outcome Measure Information:
Title
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Secondary Outcome Measure Information:
Title
Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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 Finland, MedInfoNord@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
City
Oulu
ZIP/Postal Code
70211
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Paris
ZIP/Postal Code
75012
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France

12. IPD Sharing Statement

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

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