Clinical and biochemical factors associated with risk of total joint replacement and radiographic progression in osteoarthritis: Data from two phase III clinical trials
Seminars in Arthritis and Rheumatism Dec 11, 2020
Bihlet AR, Bjerre-Bastos JJ, Andersen JR, et al. - Given that clinical trials of new disease-modifying treatments for osteoarthritis should show a positive impact on a functional outcome or decrease in joint failure in order to be regarded as successful, and because great disparity in the incidence of total joint replacement (TJR) complicates its use as a study endpoint, therefore, researchers evaluated the worth of a series of baseline clinical variables including the uCTX-II biomarker, as predictors of joint-space narrowing, Kellgren-Lawrence-grade progression, and total joint replacement. For this purpose, they used cumulative data from two phase three clinical trials with urine samples from 1,255 knee OA patients observed for two years. Experts found that prediction of TJR during a two-year period was acceptably afforded by a composite model integrating baseline age, gender, BMI, u-CTX-II and KL-grade. u-CTX-II was identified as an independent contributor to prediction of TJR, in the absence of baseline radiographic OA severity. Findings revealed a link between baseline urine CTX-II and risk of radiographic progression.
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