Osteoarthritis, KneePhase 4LEGSNCT00513422
The Long-term Evaluation of Glucosamine Sulphate Study
A Phase 4 study testing Glucosamine sulphate and chondroitin, Glucosamine sulphate and Chondroitin sulphate in people with Osteoarthritis, Knee, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Glucosamine sulphate and chondroitin, Glucosamine sulphate and Chondroitin sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2007to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unstable diabetes
- <2mm medial tibio-femoral compartment joint space width
Trial locations and contacts
1 site in 1 country.
About this 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.
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:
Read more
- 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
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Glucosamine sulphate and chondroitin, Glucosamine sulphate, Chondroitin sulphate, Placebo capsules for glucosamine and chondroitin
- Keywords
- Osteoarthritis, knee, Glucosamine, Chondroitin, Disease progression, NSAIDs
- Medical subject headings
- Osteoarthritis, Knee, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine sulphate and chondroitinDietary supplement
Also called Glucosamine, Chondroitin
Glucosamine: Two 750mg capsules once daily for two years;
Chondroitin: Two 400mg capsules once daily for two years.
Glucosamine sulphateDietary supplement
Also called Glucosamine
Glucosamine: Two 750mg capsules once daily for two years;
Placebo Chondroitin: Two capsules once daily for two years.
Chondroitin sulphateDietary supplement
Also called Chondroitin
Chondroitin sulphate: Two 400mg capsules once daily for two years;
Placebo glucosamine: Two capsules once daily for two years.
Placebo capsules for glucosamine and chondroitinDietary supplement
Also called Double placebo
Two placebo glucosamine capsules once daily for two years;
Two placebo chondroitin capsules once daily for two years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine) Receives: Dietary Supplement: Glucosamine sulphate and chondroitin |
| 2 | Experimental | Glucosamine sulfate 1500mg Receives: Dietary Supplement: Glucosamine sulphate |
| 3 | Experimental | Chondroitin sulfate 800mg Receives: Dietary Supplement: Chondroitin sulphate |
| 4 | Placebo comparator | Matching glucosamine/chondroitin placebo capsules Receives: Dietary Supplement: Placebo capsules for glucosamine and chondroitin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial tibio-femoral joint space narrowing (mm)
Measured: MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)
Measured: Bimonthly for 1 year
Secondary outcomes (6)
WOMAC
Measured: 1 year, 2 years
Patients global assessment
Measured: Bimonthly for 1 year
Total NSAIDs use
Measured: Bimonthly for 1 year
General health status (SF-12v2)
Measured: 1 year, 2 years
Cost-effectiveness (cost per OMERACT-OARSI responder)
Measured: 2 years
Leisure time physical activity
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Investigators
- Marlene Fransen, PhD, MPH, Principal investigator, University of Sydney, Faculty of Health SciencesRichard Day, MB, BS, MD, Principal investigator, University of New South WalesCharles Bridges-Webb, MB, BS, Principal investigator, Royal College of General PractitionersJohn Edmonds, MB,BS, Principal investigator, University of New South WalesRobyn Norton, PhD, MPH, Principal investigator, The George Institute, University of SydneyMark Woodward, PhD, MSc, Principal investigator, The George Institute, University of SydneyLynette March, PhD, MB, BS, Principal investigator, University of SydneyPhilip Sambrook, MB, BS, Principal investigator, Institute of Bone and Joint Research, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513422
- Sponsor's protocol ID
- GI-IM-LEGS-L
- Other IDs
- NHMRC 402511, NHMRC 402781
- Acronym
- LEGS
- Status last verified
- Jun 2010
- First submitted
- 7 Aug 2007
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34088340Fransen 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.
PubMed 24395557Laba 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.
PubMed 23647688
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
- ClinicalTrials.gov ID
- NCT00513422
- Acronym / sponsor ID
- LEGS / GI-IM-LEGS-L
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, knee, Glucosamine, Chondroitin, Disease progression, NSAIDs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- Oct 2007
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Glucosamine sulphate and chondroitinGlucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine) |
| 2 | Experimental | Dietary Supplement: Glucosamine sulphateGlucosamine sulfate 1500mg |
| 3 | Experimental | Dietary Supplement: Chondroitin sulphateChondroitin sulfate 800mg |
| 4 | Placebo comparator | Dietary Supplement: Placebo capsules for glucosamine and chondroitinMatching glucosamine/chondroitin placebo capsules |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unstable diabetes
- <2mm medial tibio-femoral compartment joint space width
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine sulphate and chondroitinAlso: Glucosamine, ChondroitinGlucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years. | Dietary supplement | 1 |
| Glucosamine sulphateAlso: GlucosamineGlucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years. | Dietary supplement | 2 |
| Chondroitin sulphateAlso: ChondroitinChondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years. | Dietary supplement | 3 |
| Placebo capsules for glucosamine and chondroitinAlso: Double placeboTwo placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years. | Dietary supplement | 4 |
Primary outcome
Medial tibio-femoral joint space narrowing (mm)
Time frame: MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)
Time frame: Bimonthly for 1 year
6 secondary outcomes
WOMAC
Time frame: 1 year, 2 years
Patients global assessment
Time frame: Bimonthly for 1 year
Total NSAIDs use
Time frame: Bimonthly for 1 year
General health status (SF-12v2)
Time frame: 1 year, 2 years
Cost-effectiveness (cost per OMERACT-OARSI responder)
Time frame: 2 years
Leisure time physical activity
Time frame: 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Derived from this study: PubMed 34088340Simic 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.
- Derived from this study: PubMed 24395557Fransen 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.
- Derived from this study: PubMed 23647688Laba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Fransen, PhD, MPH principal investigator
University of Sydney, Faculty of Health Sciences
Richard Day, MB, BS, MD principal investigator
University of New South Wales
Charles Bridges-Webb, MB, BS principal investigator
Royal College of General Practitioners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucosamine sulphate and chondroitin, Glucosamine sulphate and Chondroitin sulphate in people with Osteoarthritis, Knee, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial tibio-femoral joint space narrowing (mm) (time frame: MRI (1 year) Radiographs (2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00513422, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010.