The Long-term Evaluation of Glucosamine Sulphate Study

Osteoarthritis, Knee Clinical Trial

— LEGS  

Official title:

The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00513422
• Other study ID #: GI-IM-LEGS-L
• Secondary ID: NHMRC 402511NHMR
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 7, 2007
• Last updated: June 29, 2010
• Start date: October 2007
• Est. completion date: October 2011

Study information

• Verified date: June 2010
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease Progression
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Glucosamine sulphate and chondroitin
Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.
• Glucosamine sulphate
Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.
• Chondroitin sulphate
Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.
• Placebo capsules for glucosamine and chondroitin
Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.

Locations

Country	Name	City	State
Australia	Marlene Fransen	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
University of Sydney	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medial tibio-femoral joint space narrowing (mm)		MRI (1 year) Radiographs (2 years)	No
Primary	Knee pain (11 point Likert scale)		Bimonthly for 1 year	No
Secondary	WOMAC		1 year, 2 years	No
Secondary	Patients global assessment		Bimonthly for 1 year	No
Secondary	Total NSAIDs use		Bimonthly for 1 year	Yes
Secondary	General health status (SF-12v2)		1 year, 2 years	No
Secondary	Cost-effectiveness (cost per OMERACT-OARSI responder)		2 years	No
Secondary	Leisure time physical activity		1 year, 2 years	No

External Links

•   Study web site