Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/99829
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Type: Journal article
Title: Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? Study protocol for a randomised controlled trial
Author: Wang, Y.
Tonkin, A.
Jones, G.
Hill, C.
Ding, C.
Wluka, A.
Forbes, A.
Cicuttini, F.
Citation: Trials, 2015; 16(1):584-1-584-10
Publisher: BioMed Central
Issue Date: 2015
ISSN: 1745-6215
1745-6215
Statement of
Responsibility: 
Yuanyuan Wang, Andrew Tonkin, Graeme Jones, Catherine Hill, Changhai Ding, Anita E. Wluka, Andrew Forbes and Flavia M. Cicuttini
Abstract: Background: Osteoarthritis (OA) is a major clinical and public health problem, with no current medications approved as having disease modifying effects. HMG-CoA reductase inhibitors, or “statins”, a drug class widely used to prevent cardiovascular events, could potentially affect OA progression via a number of mechanisms including their effects on lipid metabolism and inflammation. The aim of this multicentre, randomised, double-blind, placebo-controlled trial is to determine whether atorvastatin reduces the progression of knee structural changes and symptoms over 2 years in patients with symptomatic knee OA. Methods/design: 350 patients with symptomatic knee OA will be recruited through the OA Clinical Trial Network (in Melbourne, Hobart and Adelaide). They will be randomly allocated to the two arms of the study, receiving either 40 mg of atorvastatin or identical placebo once daily for 2 years. Magnetic resonance imaging of the knee will be performed at baseline and 2 years later. Knee structure, symptoms and function will be assessed using validated methods. The primary outcome is annual percentage change in knee cartilage volume. Secondary outcomes include progression of cartilage defects, bone marrow lesions, knee pain and function. The primary analysis will be by intention to treat, but per protocol analyses will also be performed. Discussion: The study will provide high-quality evidence to address whether atorvastatin has a novel disease modifying effect in OA by delaying the structural and symptomatic progression of knee OA. Thus, the trial has major public health and clinical importance, as if found to be beneficial, atorvastatin could produce substantial cost savings by delaying and possibly reducing the need for joint replacement surgery, and provide marked improvements in quality of life for people with OA. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000190707, registered on 18 February 2013.
Keywords: Statins; osteoarthritis; cartilage; pain; magnetic resonance imaging
Rights: © Wang et al. 2015. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
RMID: 0030047080
DOI: 10.1186/s13063-015-1122-2
Grant ID: http://purl.org/au-research/grants/nhmrc/1048581
http://purl.org/au-research/grants/nhmrc/1065464
http://purl.org/au-research/grants/nhmrc/1023222
http://purl.org/au-research/grants/nhmrc/1063574
Appears in Collections:Medicine publications

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