Trial | NCT00513422  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    chondroitin glucosamine ...

  • Study Participants

    600
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
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.
Study Started
Oct 31
2007
Primary Completion
Oct 31
2011
Anticipated
Study Completion
Oct 31
2011
Anticipated
Last Update
Jun 30
2010
Estimate

Dietary Supplement Glucosamine sulphate and chondroitin

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

  • Other names: Glucosamine, Chondroitin

Dietary Supplement Glucosamine sulphate

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

  • Other names: Glucosamine

Dietary Supplement Chondroitin sulphate

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

  • Other names: Chondroitin

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.

  • Other names: Double placebo

1 Experimental

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

2 Experimental

Glucosamine sulfate 1500mg

3 Experimental

Chondroitin sulfate 800mg

4 Placebo Comparator

Matching glucosamine/chondroitin placebo capsules

Criteria 

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
No Results Posted