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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00513422




Registration number
NCT00513422
Ethics application status
Date submitted
7/08/2007
Date registered
8/08/2007
Date last updated
30/06/2010

Titles & IDs
Public title
The Long-term Evaluation of Glucosamine Sulphate Study
Scientific title
The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
Secondary ID [1] 0 0
NHMRC 402511
Secondary ID [2] 0 0
GI-IM-LEGS-L
Universal Trial Number (UTN)
Trial acronym
LEGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Glucosamine sulphate and chondroitin
Other interventions - Glucosamine sulphate
Other interventions - Chondroitin sulphate
Other interventions - Placebo capsules for glucosamine and chondroitin

Experimental: 1 - Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)

Experimental: 2 - Glucosamine sulfate 1500mg

Experimental: 3 - Chondroitin sulfate 800mg

Placebo Comparator: 4 - Matching glucosamine/chondroitin placebo capsules


Other interventions: Glucosamine sulphate and chondroitin
Glucosamine: Two 750mg capsules once daily for two years;
Chondroitin: Two 400mg capsules once daily for two years.

Other interventions: Glucosamine sulphate
Glucosamine: Two 750mg capsules once daily for two years;
Placebo Chondroitin: Two capsules once daily for two years.

Other interventions: Chondroitin sulphate
Chondroitin sulphate: Two 400mg capsules once daily for two years;
Placebo glucosamine: Two capsules once daily for two years.

Other interventions: Placebo capsules for glucosamine and chondroitin
Two placebo glucosamine capsules once daily for two years;
Two placebo chondroitin capsules once daily for two years.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Medial tibio-femoral joint space narrowing (mm)
Timepoint [1] 0 0
MRI (1 year) Radiographs (2 years)
Primary outcome [2] 0 0
Knee pain (11 point Likert scale)
Timepoint [2] 0 0
Bimonthly for 1 year
Secondary outcome [1] 0 0
WOMAC
Timepoint [1] 0 0
1 year, 2 years
Secondary outcome [2] 0 0
Patients global assessment
Timepoint [2] 0 0
Bimonthly for 1 year
Secondary outcome [3] 0 0
Total NSAIDs use
Timepoint [3] 0 0
Bimonthly for 1 year
Secondary outcome [4] 0 0
General health status (SF-12v2)
Timepoint [4] 0 0
1 year, 2 years
Secondary outcome [5] 0 0
Cost-effectiveness (cost per OMERACT-OARSI responder)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Leisure time physical activity
Timepoint [6] 0 0
1 year, 2 years

Eligibility
Key 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
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unstable diabetes

- <2mm medial tibio-femoral compartment joint space width

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2011
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Marlene Fransen - Sydney
Recruitment postcode(s) [1] 0 0
1825 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00513422
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marlene Fransen, PhD, MPH
Address 0 0
University of Sydney, Faculty of Health Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00513422