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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00513422
Recruitment Status : Unknown
Verified June 2010 by University of Sydney.
Recruitment status was:  Active, not recruiting
First Posted : August 8, 2007
Last Update Posted : June 30, 2010
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by:
University of Sydney

Tracking Information
First Submitted Date  ICMJE August 7, 2007
First Posted Date  ICMJE August 8, 2007
Last Update Posted Date June 30, 2010
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Medial tibio-femoral joint space narrowing (mm) [ Time Frame: MRI (1 year) Radiographs (2 years) ]
  • Knee pain (11 point Likert scale) [ Time Frame: Bimonthly for 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
  • Tibio-femoral joint space narrowing [ Time Frame: MRI (1 year) Radiographs (2 years) ]
  • Total oral NSAIDs dose [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00513422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • WOMAC [ Time Frame: 1 year, 2 years ]
  • Patients global assessment [ Time Frame: Bimonthly for 1 year ]
  • Total NSAIDs use [ Time Frame: Bimonthly for 1 year ]
  • General health status (SF-12v2) [ Time Frame: 1 year, 2 years ]
  • Cost-effectiveness (cost per OMERACT-OARSI responder) [ Time Frame: 2 years ]
  • Leisure time physical activity [ Time Frame: 1 year, 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
  • WOMAC [ Time Frame: 1 year, 2 years ]
  • Patients global assessment [ Time Frame: 1 year ]
  • 50 foot walk time [ Time Frame: 1 year, 2 years. ]
  • SF-12v2 [ Time Frame: 1 year, 2 years ]
  • Cost-effectiveness (cost per OMERACT-OARSI responder) [ Time Frame: 2 years ]
  • Leisure time physical activity [ Time Frame: 1 year, 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Long-term Evaluation of Glucosamine Sulphate Study
Official Title  ICMJE The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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 Name: 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 Name: 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 Name: Double placebo
Study Arms  ICMJE
  • Experimental: 1
    Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
    Intervention: Dietary Supplement: Glucosamine sulphate and chondroitin
  • Experimental: 2
    Glucosamine sulfate 1500mg
    Intervention: Dietary Supplement: Glucosamine sulphate
  • Experimental: 3
    Chondroitin sulfate 800mg
    Intervention: Dietary Supplement: Chondroitin sulphate
  • Placebo Comparator: 4
    Matching glucosamine/chondroitin placebo capsules
    Intervention: Dietary Supplement: Placebo capsules for glucosamine and chondroitin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
600
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2007)
940
Estimated Study Completion Date  ICMJE October 2011
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00513422
Other Study ID Numbers  ICMJE GI-IM-LEGS-L
NHMRC 402511 ( Other Grant/Funding Number: National Health and Medical Research Council of Australia )
NHMRC 402781 ( Other Grant/Funding Number: National Health and Medical Research Council of Australia )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Marlene Fransen, University of Sydney
Study Sponsor  ICMJE University of Sydney
Collaborators  ICMJE National Health and Medical Research Council, Australia
Investigators  ICMJE
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
PRS Account University of Sydney
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP