ANZCTR - Registration

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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

Condition category

Condition code

Musculoskeletal

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]

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]

Knee pain (11 point Likert scale)

Timepoint [1]

0, 2, 4, 6, 8, 10, 12 months

Primary outcome [2]

Medial tibiofemoral joint space narrowing (mm)

Timepoint [2]

1 year, 2 years

Secondary outcome [1]

Knee pain and function (WOMAC)

Timepoint [1]

0, 1 year, 2 years

Secondary outcome [2]

General health status (SF-12)

Timepoint [2]

0, 1 year, 2 years

Secondary outcome [3]

Leisure time physical activity

Timepoint [3]

0, 1 year, 2 years

Secondary outcome [4]

50ft walk time

Timepoint [4]

0, 1 year, 2 years

Secondary outcome [5]

Patient global assessment

Timepoint [5]

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Canberra

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Marlene Fransen

Address

Faculty of Health Sciences,
University of Sydney
PO Box 456
Lidcombe 1825

Country

Australia

Phone

61 2 93519829

Fax

m.fransen@usyd.edu.au

Contact person for scientific queries

Name

Dr Marlene Fransen

Address

Faculty of Health Sciences,
University of Sydney
PO Box 456
Lidcombe 1825

Country

Australia

Phone

61 2 9351 9829

Fax

m.fransen@usyd.edu.au

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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