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ISRCTN
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ISRCTN54513166
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ClinicalTrials.gov identifier
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Public title
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Glucosamine in osteoarthritis: long-term effectiveness
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Scientific title
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Acronym
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GOAL
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Serial number at source
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N/A
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Study hypothesis
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Pharmacological treatment for osteoarthritis (OA) can be divided into two groups: symptom-modifying drugs and disease-modifying drugs. Symptom-modifying drugs are currently the prescription of choice for patients with OA, as disease-modifying drugs are not yet available in usual care. However, there has recently been a lot of debate about glucosamine sulphate (GS), a biological agent that is thought to have both symptom-modifying and disease-modifying properties. This assumption has yet to be proved. This blind randomised clinical trial examines the long-term symptom-modifying and disease-modifying effectiveness of GS in patients with hip OA.
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Ethics approval
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Trial approved by the Medical Ethics Committee at the Erasmus MC - University Medical Centre Rotterdam.
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Study design
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Randomised, blinded, placebo-controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Osteoarthritis
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Participants - inclusion criteria
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Patients are eligible for participation when they meet one of the American College of Rheumatology (ACR) criteria for osteoarthritis of the hip.
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Participants - exclusion criteria
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1. Patients that have already undergone hip replacement surgery
2. Patients on the waiting list for hip replacement surgery
3. Patients that have a Kellgren-Lawrence score of 4
4. Patients with renal or hepatic disease or diabetes mellitus or a disabling co-morbidity
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Anticipated start date
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01/10/2003
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Anticipated end date
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31/03/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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222
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Interventions
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Patients are randomised to either 1500 mg of oral glucosamine sulphate or a placebo daily for the duration of two years.
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Primary outcome measure(s)
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The primary outcome measures, which are joint space narrowing (JSN), and change in the pain and function score of the Western Ontario McMaster Universities Osteoarthritis index (WOMAC), are determined at baseline and after two years of follow-up during the final assessment. Intermediate measures at three-month intervals throughout the trial are used to study secondary outcome measures.
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Secondary outcome measure(s)
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Secondary outcome measures are changes in WOMAC stiffness score, quality of life, medical consumption, side effects and differences in biomarker CTX-II.
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Sources of funding
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Erasmus Medical Centre (The Netherlands) - Breedtestrategie
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Trial website
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Publications
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1. Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/15850497
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18283204
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Contact name
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Dr
Sita M.A.
Bierma-Zeinstra
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Address
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Department of General Practice, room Ff320
Erasmus MC
PO Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 408 7633
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Fax
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+31 (0)10 408 9491
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Email
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s.bierma-zeinstra@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (The Netherlands)
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Address
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Board of Directors
PO Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 463 2578
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Fax
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+31 (0)10 463 2583
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Email
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c.festen@erasmusmc.nl
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Date applied
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14/01/2005
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Last edited
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22/02/2008
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Date ISRCTN assigned
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08/03/2005
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