The Long-term Evaluation of Glucosamine Sulphate Study
LEGS
The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
3 other identifiers
interventional
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 30, 2010
June 1, 2010
4 years
August 7, 2007
June 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Medial tibio-femoral joint space narrowing (mm)
MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)
Bimonthly for 1 year
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (4)
1
EXPERIMENTALGlucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
2
EXPERIMENTALGlucosamine sulfate 1500mg
3
EXPERIMENTALChondroitin sulfate 800mg
4
PLACEBO COMPARATORMatching glucosamine/chondroitin placebo capsules
Interventions
Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.
Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.
Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.
Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unstable diabetes
- \<2mm medial tibio-femoral compartment joint space width
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marlene Fransen
Sydney, New South Wales, 1825, Australia
Related Publications (3)
Simic M, Harmer AR, Agaliotis M, Nairn L, Bridgett L, March L, Votrubec M, Edmonds J, Woodward M, Day R, Fransen M. Clinical risk factors associated with radiographic osteoarthritis progression among people with knee pain: a longitudinal study. Arthritis Res Ther. 2021 Jun 4;23(1):160. doi: 10.1186/s13075-021-02540-9.
PMID: 34088340DERIVEDFransen M, Agaliotis M, Nairn L, Votrubec M, Bridgett L, Su S, Jan S, March L, Edmonds J, Norton R, Woodward M, Day R; LEGS study collaborative group. Glucosamine and chondroitin for knee osteoarthritis: a double-blind randomised placebo-controlled clinical trial evaluating single and combination regimens. Ann Rheum Dis. 2015 May;74(5):851-8. doi: 10.1136/annrheumdis-2013-203954. Epub 2014 Jan 6.
PMID: 24395557DERIVEDLaba TL, Brien JA, Fransen M, Jan S. Patient preferences for adherence to treatment for osteoarthritis: the MEdication Decisions in Osteoarthritis Study (MEDOS). BMC Musculoskelet Disord. 2013 May 6;14:160. doi: 10.1186/1471-2474-14-160.
PMID: 23647688DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 7, 2007
First Posted
August 8, 2007
Study Start
October 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 30, 2010
Record last verified: 2010-06