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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN54513166 |
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Date of registration:
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08/03/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/10/2003 |
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Target sample size:
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222 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN54513166 |
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Study type:
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Interventional |
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Study design:
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Randomised, blinded, placebo-controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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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
3000 CA
Rotterdam
Netherlands |
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Telephone:
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+31 (0)10 408 7633 |
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Email:
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s.bierma-zeinstra@erasmusmc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients are eligible for participation when they meet one of the American College of Rheumatology (ACR) criteria for osteoarthritis of the hip.
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
Musculoskeletal Diseases
Osteoarthritis (OA)
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Intervention(s)
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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(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(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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Source(s) of Monetary Support
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Erasmus Medical Centre (The Netherlands) - Breedtestrategie
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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