The primary aim of this study is to determine if the dietary supplements, glucosamine sulphate and/or chondroitin can limit or reduce structural disease progression whilst providing symptomatic benefit in people with osteoarthritis (OA) of the knee. The specific hypotheses to be tested in the proposed double blind, placebo-controlled, randomised clinical trial are that, compared to participants allocated to placebo, participants allocated to either or both of these dietary supplements will demonstrate: * reduced medial tibio-femoral joint space narrowing at 2 years AND; * reduced knee pain over 1 year These benefits will be achieved by participants allocated to glucosamine sulphate and/or chondroitin (the study treatments) without concomitant: * increased use of analgesics * reduced health-related quality of life * reduced participation in leisure-time physical activity
The LEGS study is a double blind, placebo-controlled randomised clinical trial using a 2 x 2 factorial design. Participant will be randomly allocated to one of the four possible treatment combinations: * Glucosamine and Chondroitin (double active) * Placebo Glucosamine and Chondroitin * Glucosamine and Placebo Chondroitin * Placebo Glucosamine and Placebo Chondroitin (double placebo) Each allocation involves taking 4 study treatment capsules once a day for two years. A total of 600 participants with symptomatic knee OA will be recruited by general media advertising and by General Practitioners through the New South Wales Divisions of general practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.
Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.
Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.
Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.
Marlene Fransen
Sydney, New South Wales, Australia
Medial tibio-femoral joint space narrowing (mm)
Time frame: MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)
Time frame: Bimonthly for 1 year
WOMAC
Time frame: 1 year, 2 years
Patients global assessment
Time frame: Bimonthly for 1 year
Total NSAIDs use
Time frame: Bimonthly for 1 year
General health status (SF-12v2)
Time frame: 1 year, 2 years
Cost-effectiveness (cost per OMERACT-OARSI responder)
Time frame: 2 years
Leisure time physical activity
Time frame: 1 year, 2 years
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