The Long-term Evaluation of Glucosamine Sulphate Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-10-31

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.

Conditions

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Osteoarthritis, Knee

Keywords

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Osteoarthritis, knee Glucosamine Chondroitin Disease progression NSAIDs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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