Back to resultsStudy Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
rhBMP-2/CPM
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Osteoarthritis focused on measuring osteoarthritis, deformity of knee
Eligibility Criteria
Inclusion Criteria: Male or female subjects 45 to 70 years of age Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee. Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study. Other inclusion applies. Exclusion Criteria: Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results. Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up. Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma. Other exclusion applies.
Sites / Locations
Outcomes
Primary Outcome Measures
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
Feasibility measures include
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
Secondary Outcome Measures
Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.
Full Information
NCT ID
NCT00243295
First Posted
October 19, 2005
Last Updated
October 5, 2006
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00243295
Brief Title
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Official Title
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
Injecting the desired volume of rhBMP-2/CPM within the defect
Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, deformity of knee
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rhBMP-2/CPM
Primary Outcome Measure Information:
Title
Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
Title
Feasibility measures include
Title
Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
Title
Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.
Secondary Outcome Measure Information:
Title
Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 45 to 70 years of age
Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.
Other inclusion applies.
Exclusion Criteria:
Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.
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
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
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