The Long-term Evaluation of Glucosamine Sulphate Study

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Dietary Supplement: Glucosamine sulphate and chondroitin
* Dietary Supplement: Glucosamine sulphate
* Dietary Supplement: Chondroitin sulphate
* Dietary Supplement: Placebo capsules for glucosamine and chondroitin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee pain, or taking NSAIDs/ analgesia for knee pain on most days past month Knee pain 4-10 on 10cm VAS Medial tibio-femoral compartment joint space narrowing in symptomatic knee Exclusion Criteria: Unstable diabetes <2mm medial tibio-femoral compartment joint space width

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine) | Dietary Supplement: Glucosamine sulphate and chondroitin<br>* Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.<br>* Other names: Chondroitin;|
| Experimental: 2<br>Glucosamine sulfate 1500mg | Dietary Supplement: Glucosamine sulphate<br>* Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.<br>* Other names: Glucosamine;|
| Experimental: 3<br>Chondroitin sulfate 800mg | Dietary Supplement: Chondroitin sulphate<br>* Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.<br>* Other names: Chondroitin;|
| Placebo Comparator: 4<br>Matching glucosamine/chondroitin placebo capsules | Dietary Supplement: Placebo capsules for glucosamine and chondroitin<br>* Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.<br>* Other names: Double placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medial tibio-femoral joint space narrowing (mm) |  | MRI (1 year) Radiographs (2 years) | 
| Knee pain (11 point Likert scale) |  | Bimonthly for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | 1 year, 2 years | 
| Patients global assessment |  | Bimonthly for 1 year | 
| Total NSAIDs use |  | Bimonthly for 1 year | 
| General health status (SF-12v2) |  | 1 year, 2 years | 
| Cost-effectiveness (cost per OMERACT-OARSI responder) |  | 2 years | 
| Leisure time physical activity |  | 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, knee, Glucosamine, Chondroitin, Disease progression, NSAIDs