Clinical trial NCT00513422: The Long-term Evaluation of Glucosamine Sulphate Study
Official title: The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, knee
Glucosamine
Chondroitin
Disease progression
NSAIDs
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2007-08-08
Enrollment: 600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Medial tibio-femoral joint space narrowing (mm)
timeFrame: MRI (1 year) Radiographs (2 years)
measure: Knee pain (11 point Likert scale)
timeFrame: Bimonthly for 1 year
Secondary outcomes:
measure: WOMAC
timeFrame: 1 year, 2 years
measure: Patients global assessment
timeFrame: Bimonthly for 1 year
measure: Total NSAIDs use
timeFrame: Bimonthly for 1 year
measure: General health status (SF-12v2)
timeFrame: 1 year, 2 years
measure: Cost-effectiveness (cost per OMERACT-OARSI responder)
timeFrame: 2 years
measure: Leisure time physical activity
timeFrame: 1 year, 2 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Marlene Fransen
state: New South Wales
Study officials:
affiliation: University of Sydney, Faculty of Health Sciences
name: Marlene Fransen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New South Wales
name: Richard Day, MB, BS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of General Practitioners
name: Charles Bridges-Webb, MB, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New South Wales
name: John Edmonds, MB,BS
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute, University of Sydney
name: Robyn Norton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute, University of Sydney
name: Mark Woodward, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Lynette March, PhD, MB, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Bone and Joint Research, University of Sydney
name: Philip Sambrook, MB, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fransen 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.
citation: Laba 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.