- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074476
Effects of Glucosamine on Joint Fluid in Osteoarthritis Patients
Investigation of Oral Glucosamine Effects on Synovial Fluid Viscosity and Viscoelasticity in Osteoarthritis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
The effectiveness of glucosamine sulphate as a treatment for OA is still under debate. Most clinical trials evaluate the effectiveness of OA treatments by self-administered questionnaires about joint pain, stiffness and function (Lequesne Algofunctional Index, Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC).
Although OA has been shown to reduce the viscosity and viscoelasticity of synovial fluid, few studies have used these properties as objective outcome measures in the assessment of glucosamine therapy.
The purpose of this study is to investigate whether glucosamine sulphate oral supplements improve the viscous and viscoelastic properties of synovial fluid in osteoarthritis patients and to explore potential correlations between these properties and subjective assessments of joint pain and function.
Research Method:
Patients will be invited to participate in the study if they have been recommended for synovial fluid aspiration to relieve joint discomfort caused by effusion. Subjects will be randomly assigned to receive either 1500mg of glucosamine sulphate or a placebo daily for 3 months. To relieve pain, subjects will be allowed to take up to 4000 mg of acetaminophen per day. If this is insufficient, NSAIDS will be permitted up to a maximum period of 5 consecutive days. Subjects will be asked to keep a log of their analgesics consumption.
At the baseline visit, patient demographics will be recorded and subjects will be asked to complete the WOMAC index questionnaire, which includes 24 questions to evaluate joint pain, stiffness and physical function. After noting the degree of joint effusion (minor, moderate, severe), an experienced physician will aspirate synovial fluid from the study knee to relieve joint pressure. A sample will be collected for analysis of viscosity and viscoelasticity.
Followup visits will be scheduled after every 4 weeks over the 3-month study period. Each visit will include the completion of a WOMAC questionnaire, clinical assessment of the degree of joint effusion and aspiration of synovial fluid (as necessary) for characterization. Any adverse events (such as headaches, abdominal pain, allergic episodes) will also be reported to the physician.
Changes in synovial fluid viscosity and viscoelasticity will be determined after 3 months of glucosamine supplementation and compared to the placebo group. Correlations between synovial fluid properties and WOMAC scores will also be described.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre
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Vancouver, British Columbia, Canada, V6T 1Z3
- University of British Columbia Health Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- are between 30 and 85 years of age
- are clinically diagnosed with moderate to severe knee OA
- are recommended for synovial fluid aspiration
Exclusion Criteria:
- are clinically diagnosed with inflammatory arthritis
- had previous joint surgery in the study knee
- had injection in the study knee within the past 12 months
- have taken glucosamine and/or chondroitin supplements within the past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Glucosamine sulphate tablets
|
750mg glucosamine sulphate (oral tablets), twice per day for 3 months
|
Placebo Comparator: 2
Placebo tablets
|
Placebo tablets, twice per day for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in synovial fluid viscosity and viscoelasticity compared to baseline
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ezra Kwok, Dr, University of British Columbia
- Study Director: Dana Grecov, Dr., University of British Columbia
- Study Director: Christie Newton, Dr., University of British Columbia
Publications and helpful links
General Publications
- Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808. doi: 10.1056/NEJMoa052771.
- Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology. 2007;44(2):59-74.
- Anadere I, Chmiel H, Laschner W. Viscoelasticity of "normal" and pathological synovial fluid. Biorheology. 1979;16(3):179-84. doi: 10.3233/bir-1979-16306. No abstract available.
- Schurz J, Ribitsch V. Rheology of synovial fluid. Biorheology. 1987;24(4):385-99. doi: 10.3233/bir-1987-24404.
- Vangsness CT Jr, Spiker W, Erickson J. A review of evidence-based medicine for glucosamine and chondroitin sulfate use in knee osteoarthritis. Arthroscopy. 2009 Jan;25(1):86-94. doi: 10.1016/j.arthro.2008.07.020. Epub 2008 Sep 30.
- Black C, Clar C, Henderson R, MacEachern C, McNamee P, Quayyum Z, Royle P, Thomas S. The clinical effectiveness of glucosamine and chondroitin supplements in slowing or arresting progression of osteoarthritis of the knee: a systematic review and economic evaluation. Health Technol Assess. 2009 Nov;13(52):1-148. doi: 10.3310/hta13520.
- Matsuno H, Nakamura H, Katayama K, Hayashi S, Kano S, Yudoh K, Kiso Y. Effects of an oral administration of glucosamine-chondroitin-quercetin glucoside on the synovial fluid properties in patients with osteoarthritis and rheumatoid arthritis. Biosci Biotechnol Biochem. 2009 Feb;73(2):288-92. doi: 10.1271/bbb.80418. Epub 2009 Feb 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-00146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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