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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Sydney.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00513422
First received: August 7, 2007
Last updated: June 29, 2010
Last verified: June 2010
History of Changes
  Purpose

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

Condition Intervention Phase
Osteoarthritis, Knee
 Dietary Supplement: Glucosamine sulphate and chondroitin
Dietary Supplement: Glucosamine sulphate
Dietary Supplement: Chondroitin sulphate
Dietary Supplement: Placebo capsules for glucosamine and chondroitin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Medial tibio-femoral joint space narrowing (mm) [ Time Frame: MRI (1 year) Radiographs (2 years) ] [ Designated as safety issue: No ]
  • Knee pain (11 point Likert scale) [ Time Frame: Bimonthly for 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Patients global assessment [ Time Frame: Bimonthly for 1 year ] [ Designated as safety issue: No ]
  • Total NSAIDs use [ Time Frame: Bimonthly for 1 year ] [ Designated as safety issue: Yes ]
  • General health status (SF-12v2) [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • Cost-effectiveness (cost per OMERACT-OARSI responder) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Leisure time physical activity [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
 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
Experimental: 2
Glucosamine sulfate 1500mg
 Dietary Supplement: Glucosamine sulphate

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

Placebo Chondroitin: Two capsules once daily for two years.

Other Name: Glucosamine
Experimental: 3
Chondroitin sulfate 800mg
 Dietary Supplement: Chondroitin sulphate

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

Placebo glucosamine: Two capsules once daily for two years.

Other Name: Chondroitin
Placebo Comparator: 4
Matching glucosamine/chondroitin placebo capsules
 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 Name: Double placebo

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513422

Locations
Australia, New South Wales
Marlene Fransen
Sydney, New South Wales, Australia, 1825
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Marlene Fransen, PhD, MPH University of Sydney, Faculty of Health Sciences
Principal Investigator: Richard Day, MB, BS, MD University of New South Wales
Principal Investigator: Charles Bridges-Webb, MB, BS Royal College of General Practitioners
Principal Investigator: John Edmonds, MB,BS University of New South Wales
Principal Investigator: Robyn Norton, PhD, MPH The George Institute, University of Sydney
Principal Investigator: Mark Woodward, PhD, MSc The George Institute, University of Sydney
Principal Investigator: Lynette March, PhD, MB, BS University of Sydney
Principal Investigator: Philip Sambrook, MB, BS Institute of Bone and Joint Research, University of Sydney
  More Information

Additional Information:
Study web site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Marlene Fransen, University of Sydney
ClinicalTrials.gov Identifier: NCT00513422     History of Changes
Other Study ID Numbers: GI-IM-LEGS-L, NHMRC 402511, NHMRC 402781
Study First Received: August 7, 2007
Last Updated: June 29, 2010
Health Authority: Australia: National Health and Medical Research Council
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by University of Sydney:
Osteoarthritis, knee
Glucosamine
Chondroitin
Disease progression
NSAIDs

Additional relevant MeSH terms:
Osteoarthritis
Disease Progression
Osteoarthritis, Knee
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013