Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00243295
• Collaborator: (none)
• Enrollment: 6
• Duration (Months): 16

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: rhBMP-2/CPM	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Educational/Counseling/Training
• 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 Start Date: Nov 1, 2003
• Study Completion Date: Mar 1, 2005

Outcome Measures

Primary Outcome Measures

1. Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies []

2. Feasibility measures include []

3. Injection of desired volume of rhBMP-2/CPM within the osteotomy defect []

4. Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM. []

Secondary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00243295
• Other Study ID Numbers: 3100N7-110
• First Posted: Oct 21, 2005
• Last Update Posted: Oct 6, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: osteoarthritis; deformity of knee
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Oct 6, 2006