The Long-term Evaluation of Glucosamine Sulphate Study (LEGS)

University of Sydney

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Dietary Supplement: Placebo capsules for glucosamine and chondroitin; Dietary Supplement: Glucosamine sulphate and chondroitin; Dietary Supplement: Glucosamine sulphate; Dietary Supplement: Chondroitin sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT00513422

GI-IM-LEGS-L

NHMRC 402781 (Other Grant/Funding Number)

NHMRC 402511 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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600 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)

Treatment:

Dietary Supplement: Glucosamine sulphate and chondroitin

2

Experimental group

Description:

Glucosamine sulfate 1500mg

Treatment:

Dietary Supplement: Glucosamine sulphate

3

Experimental group

Description:

Chondroitin sulfate 800mg

Treatment:

Dietary Supplement: Chondroitin sulphate

4

Placebo Comparator group

Description:

Matching glucosamine/chondroitin placebo capsules

Treatment:

Dietary Supplement: Placebo capsules for glucosamine and chondroitin