The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
Single intraarticular injection of BMP-7 or placebo on Day 1
Florida Medical Research Institute
Gainesville, Florida, United States
Tufts Medical Center
Boston, Massachusetts, United States
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
Time frame: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
WOMAC pain and function
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24
Patient and physician global VAS
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
Quality of life measurement (SF-36) and pain medication use
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24
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