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The Long-term Evaluation of Glucosamine Sulphate Study

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00513422
Acronym
LEGS
Enrollment
600
Registered
2007-08-08
Start date
2007-10-31
Completion date
2011-10-31
Last updated
2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, knee, Glucosamine, Chondroitin, Disease progression, NSAIDs

Brief 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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTGlucosamine sulphate and chondroitin

Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.

DIETARY_SUPPLEMENTGlucosamine sulphate

Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.

DIETARY_SUPPLEMENTChondroitin sulphate

Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.

DIETARY_SUPPLEMENTPlacebo capsules for glucosamine and chondroitin

Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
University of Sydney
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Patients global assessmentBimonthly for 1 year
Total NSAIDs useBimonthly for 1 year
Leisure time physical activity1 year, 2 years
Cost-effectiveness (cost per OMERACT-OARSI responder)2 years
General health status (SF-12v2)1 year, 2 years
WOMAC1 year, 2 years

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026