Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000433404
Ethics application status
Approved
Date submitted
16/08/2007
Date registered
24/08/2007
Date last updated
27/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The long-term evaluation of glucosamine sulphate (LEGS) study
Scientific title
Among people with symptomatic osteoarthritis of the knee, does glucosamine sulphate, with or without chondroitin, result in reduced knee pain and slowing the rate of joint space narrowing
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis knee 2271 0
Condition category
Condition code
Musculoskeletal 2361 2361 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Glucosamine sulphate (1500mg) and chondroitin (800mg): two 750mg glucosamine sulphate capsules and two 400mg chondroitin capsules daily for two years
2. Glucosamine sulphate (1500mg): two 750mg glucosamine capsules and two placebo chondroitin capsules daily for two years
3. Chondroitin (800mg): two 400mg chondroitin capsules and two placebo glucosamine capsules daily for two years
Intervention code [1] 1980 0
Treatment: Other
Comparator / control treatment
Double placebo (2 capsules of inactive powder matched in taste and appearance to glucosamine sulphate capsules; 2 capsules of inactive powder matched in taste and appearance to chondroitin capsules)ondroitin placebo, daily for two years
Control group
Placebo

Outcomes
Primary outcome [1] 3259 0
Knee pain (11 point Likert scale)
Timepoint [1] 3259 0
0, 2, 4, 6, 8, 10, 12 months
Primary outcome [2] 3260 0
Medial tibiofemoral joint space narrowing (mm)
Timepoint [2] 3260 0
1 year, 2 years
Secondary outcome [1] 5359 0
Knee pain and function (WOMAC)
Timepoint [1] 5359 0
0, 1 year, 2 years
Secondary outcome [2] 5361 0
General health status (SF-12)
Timepoint [2] 5361 0
0, 1 year, 2 years
Secondary outcome [3] 5362 0
Leisure time physical activity
Timepoint [3] 5362 0
0, 1 year, 2 years
Secondary outcome [4] 5363 0
50ft walk time
Timepoint [4] 5363 0
0, 1 year, 2 years
Secondary outcome [5] 5440 0
Patient global assessment
Timepoint [5] 5440 0
0, 2, 4, 6, 8, 10, 12 months

Eligibility
Key inclusion criteria
Chronic knee pain
Loss of medial tibio-femoral joint space
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unstable diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will telephone the study Research Officer who will screen for eligibility. Screening eligibility will be confirmed by signature of their nominated GP. Screened and radiologically eligibile participants will be required to complete a baseline assessment and two week run-in period prior to randomisation. Research officers randomising participants will be unaware of the randomisation schedule. An administrative officer, not associated with the LEGS study, will despatch study treatment from a central off-site location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer generated, off-site, in permuted blocks (mix of blocks of two different sizes).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2518 0
Government body
Name [1] 2518 0
National Health and Medical Research Council
Country [1] 2518 0
Australia
Primary sponsor type
University
Name
Clinical and Rehabilitation Sciences Research Group, Faculty of Health Sciences
Address
PO Box 456
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 2256 0
None
Name [1] 2256 0
Address [1] 2256 0
Country [1] 2256 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
There is no known cure for OA and no intervention demonstrated to slow disease progression or delay time to joint replacement surgery. Currently patients are managed symptomatically with all clinical guidelines recommending paracetamol as 'the preferred long term oral analgesic'. This recommendation is based on the increased risk of serious gastrointestinal, cardiovascular and renal diseases with long-term NSAIDs use in older people. However, NSAIDs appear to provide better pain relief for patients with more than mild joint pain.

Amongst patients with OA, there is much demand for the dietary supplement glucosamine and chondroitin. Marketing has led to the belief these products are able to slow the rate of joint destruction and cartilage loss and help ease joint pain with little risk of side effects. However, the few trials conducted to date have been inconclusive.
A total of 600 patients with knee OA will be randomly allocated to glucosamine sulphate and chondroitin sulphate or matching placebo capsules for two years. Participants will be required to take four capsules, once daily for two years. Clinic visits for assessment, including knee radiographs, will be required at the start of the study as well as 1 year and 2 years later. The main outcomes will be the rate of joint space narrowing, knee pain and physical disability. If glucosamine results in slowing disease progression or in reducing pain, the widespread use of this product would effectively decrease pain, disability and possibly NSAIDs-related illnesses amongst the increasing number of people with OA.
Trial website
www.fhs.usyd.edu.au/LEGS
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27750 0
Address 27750 0
Country 27750 0
Phone 27750 0
Fax 27750 0
Email 27750 0
Contact person for public queries
Name 11125 0
Dr Marlene Fransen
Address 11125 0
Faculty of Health Sciences,
University of Sydney
PO Box 456
Lidcombe 1825
Country 11125 0
Australia
Phone 11125 0
61 2 93519829
Fax 11125 0
Email 11125 0
[email protected]
Contact person for scientific queries
Name 2053 0
Dr Marlene Fransen
Address 2053 0
Faculty of Health Sciences,
University of Sydney
PO Box 456
Lidcombe 1825
Country 2053 0
Australia
Phone 2053 0
61 2 9351 9829
Fax 2053 0
Email 2053 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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