Abstract
BackgroundTPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy. This retrospective study compared MRI 3D femoral bone shape changes (B-scores) after intra-articular TPX-100 or placebo and analyzed the relationship between cartilage thickness and bone shape change over 12 months.MethodsOne hundred and four participants with bilateral moderate to severe knee cartilage defects were randomized to receive TPX-100 (200 mg) or placebo. Each subject’s contralateral placebo-treated knee served as a paired internal control. After MRI quality control, 78/93 subjects (84%; 156 knees) were analyzed for quantitative femoral B-score and cartilage thickness. All analyses were performed centrally, blind to treatment assignment and clinical data.ResultsTPX-100-treated knees (n = 78) demonstrated a statistically significant decrease in pathologic bone shape change compared with placebo-treated knees at 6 and 12 months: 0.0298 (95% C.I. − 0.037, 0.097) vs 0.1246 (95% C.I. 0.067, 0.182) (P = 0.02), and 0.0856 (95% C.I. 0.013, 0.158) vs. 0.1969 (95% C.I. 0.123, 0.271) (P = 0.01), respectively. The correlation between bone shape change and medial and total tibiofemoral cartilage thickness changes at 12 months was statistically significant in TPX-100-treated knees (P < 0.01).ConclusionsThis is the first report of a potential therapy demonstrating a significant effect on bone shape measured by B-score in knee OA. These data, in combination with previously reported statistically significant and clinically meaningful improvements in WOMAC physical function versus placebo, support TPX-100 as a candidate for disease modification in knee OA.Trial registrationNIH ClinicalTrials.gov, NCT01925261. Registered 15 August 2013
Highlights
TPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy
All per protocol (PPT) subjects: TPX-100-1, N = 93 Mean age, 58.4 (95% C.I. 56.4, 60.4) Sex, 38 males, 55 females (59.1% females) Mean body mass index (BMI), 30.4 (95% C.I. 29.1, 31.7)
Evaluable B-score analyzed cohort: TPX-100-5, N = 78 Mean age, 58.4 (95% C.I. 56.2, 60.6) Sex, 30 males, 48 females (61.5% Females) Mean BMI, 30.9 (95% C.I. 29.5, 32.3)
Summary
TPX-100, a promotor of osteoblast and chondroblast differentiation, is a potential osteoarthritis (OA) therapy This retrospective study compared MRI 3D femoral bone shape changes (B-scores) after intra-articular TPX100 or placebo and analyzed the relationship between cartilage thickness and bone shape change over 12 months. MRI-based MOAKS evaluation, including cartilage defects, meniscal pathology, and Hoffa’s synovitis, did not show differences at baseline or follow-up between TPX100-treated knees and placebo-exposed knees, and there were no significant within-knee changes in bone marrow lesions at 6 or 12 months. Post hoc analyses revealed that 68 (73%) of subjects had, in addition to the bilateral patellofemoral cartilage defects for which they were enrolled, moderate to severe (ICRS 2–4) bilateral tibiofemoral cartilage defects In these subjects, sustained, statistically significant, and clinically meaningful clinical benefits in favor of TPX-100-treated knees were observed, nearly identical to those in the whole population [6]
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