The Long-term Evaluation of Glucosamine Sulphate Study

Phase 4

• Conditions: Osteoarthritis, Knee
• Interventions: Dietary Supplement: Glucosamine sulphate and chondroitin; Dietary Supplement: Glucosamine sulphate; Dietary Supplement: Chondroitin sulphate; Dietary Supplement: Placebo capsules for glucosamine and chondroitin

• Registration Number: NCT00513422
• Lead Sponsor: University of Sydney

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.

Study Timeline

• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Study Start: 2007-10
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Glucosamine sulphate and chondroitin	Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
2	Glucosamine sulphate	Glucosamine sulfate 1500mg
3	Chondroitin sulphate	Chondroitin sulfate 800mg
4	Placebo capsules for glucosamine and chondroitin	Matching glucosamine/chondroitin placebo capsules

Primary Outcome Measures

Name	Time	Method
Medial tibio-femoral joint space narrowing (mm)	MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)	Bimonthly for 1 year

Secondary Outcome Measures

Name	Time	Method
WOMAC	1 year, 2 years
Patients global assessment	Bimonthly for 1 year
Total NSAIDs use	Bimonthly for 1 year
General health status (SF-12v2)	1 year, 2 years
Cost-effectiveness (cost per OMERACT-OARSI responder)	2 years
Leisure time physical activity	1 year, 2 years

Trial Locations

Locations (1)

Marlene Fransen; 🇦🇺 Sydney, New South Wales, Australia