Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments glucosamine sulphate and chondroitin, glucosamine sulphate, chondroitin sulphate, placebo capsules for glucosamine and chondroitin
Phase phase 4
Sponsor University of Sydney
Collaborator National Health and Medical Research Council, Australia
Start date October 2007
End date October 2011
Trial size 600 participants
Trial identifier NCT00513422, GI-IM-LEGS-L, NHMRC 402511, NHMRC 402781

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
glucosamine sulphate and chondroitin Glucosamine
Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.
(Experimental)
Glucosamine sulfate 1500mg
glucosamine sulphate Glucosamine
Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.
(Experimental)
Chondroitin sulfate 800mg
chondroitin sulphate Chondroitin
Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.
(Placebo Comparator)
Matching glucosamine/chondroitin placebo capsules
placebo capsules for glucosamine and chondroitin Double placebo
Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 45 years up to 75 years old.

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

Additional Information

Official title The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
Principal investigator Marlene Fransen, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Sydney.