The Long-term Evaluation of Glucosamine Sulphate Study — LEGS  

Osteoarthritis, Knee Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease Progression
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT00513422
• Study type: Interventional
• Source: University of Sydney
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2007
• Completion date: October 2011