Methodologic issues in clinical trials for prevention or risk reduction in Osteoarthritis

Jordan, J.M., Sowers, M.F., Messier, S.P., Bradley, J., Arangio, G., Katz, J.N., Losina, E., Rovati, L., Batchell, N., Cooper, C., Spector, T., Zhang, W., Gardiner, J. and Wahba, M. (2011) Methodologic issues in clinical trials for prevention or risk reduction in Osteoarthritis Osteoarthritis and Cartilage, 19, (5), pp. 500-508. (doi:10.1016/j.joca.2010.10.031). (PMID:21396470).


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The design and execution of prevention trials for OA have methodological issues that are distinct from trials designed to impact prevalent disease. Disease definitions and their precise and sensitive measurement, identification of high-risk populations, the nature of the intervention (pharmaceutical, nutraceutical, behavioral) and its potential pleiotropic impacts on other organ systems are critical to consider. Because prevention trials may be prolonged, close attention to concomitant life changes and co-morbidities, adherence and participant retention in the trial is of primary importance, as is recognition of the potential for “preventive misconception” and “behavioral disinhibition” to affect the ability of the trial to show an effect of the intervention under study. None of these potential pitfalls precludes a successful and scientifically rigorous process and outcome. As technology improves the means to measure and predict the OA process and its clinical consequences, it will be increasingly possible to screen individuals for high-risk phenotypes, combining clinical factors with information from imaging, genetic, metabolic and other biomarkers and to impact this high-risk condition to avoid or delay OA both structurally and symptomatically.

Item Type: Article
Digital Object Identifier (DOI): doi:10.1016/j.joca.2010.10.031
ISSNs: 1063-4584 (print)
Keywords: prevention, clinical trial, obesity, injury, osteoarthritis

ePrint ID: 187991
Date :
Date Event
May 2011Published
Date Deposited: 19 May 2011 12:43
Last Modified: 18 Apr 2017 02:07
Further Information:Google Scholar

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