The Long-term Evaluation of Glucosamine Sulphate Study

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

Conditions

• Osteoarthritis, Knee

Interventions

DIETARY_SUPPLEMENT

Glucosamine sulphate and chondroitin

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

DIETARY_SUPPLEMENT

Glucosamine sulphate

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

DIETARY_SUPPLEMENT

Chondroitin sulphate

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

DIETARY_SUPPLEMENT

Placebo capsules for glucosamine and chondroitin

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

Sponsors & Collaborators

• National Health and Medical Research Council, Australia

  collaborator OTHER

• University of Sydney

  lead OTHER

Principal Investigators

• Marlene Fransen, PhD, MPH · University of Sydney, Faculty of Health Sciences

• Richard Day, MB, BS, MD · University of New South Wales

• Charles Bridges-Webb, MB, BS · Royal College of General Practitioners

• John Edmonds, MB,BS · University of New South Wales

• Robyn Norton, PhD, MPH · The George Institute, University of Sydney

• Mark Woodward, PhD, MSc · The George Institute, University of Sydney

• Lynette March, PhD, MB, BS · University of Sydney

• Philip Sambrook, MB, BS · Institute of Bone and Joint Research, University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2011-10-31

Completion

2011-10-31

Countries

• Australia

Study Locations