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Glucosamine in osteoarthritis: long-term effectiveness
ISRCTN ISRCTN54513166
DOI 10.1186/ISRCTN54513166
ClinicalTrials.gov identifier
EudraCT number
Public title Glucosamine in osteoarthritis: long-term effectiveness
Scientific title
Acronym GOAL
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Trial approved by the Medical Ethics Committee at the Erasmus MC - University Medical Centre Rotterdam.
Study design Randomised, blinded, placebo-controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Osteoarthritis
Participants - inclusion criteria Patients are eligible for participation when they meet one of the American College of Rheumatology (ACR) criteria for osteoarthritis of the hip.
Participants - 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
Anticipated start date 01/10/2003
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 222
Interventions Patients are randomised to either 1500 mg of oral glucosamine sulphate or a placebo daily for the duration of two years.
Primary outcome measure(s) 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.
Secondary outcome measure(s) Secondary outcome measures are changes in WOMAC stiffness score, quality of life, medical consumption, side effects and differences in biomarker CTX-II.
Sources of funding Erasmus Medical Centre (The Netherlands) - Breedtestrategie
Trial website
Publications 1. Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/15850497
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18283204
Contact name Dr  Sita M.A.  Bierma-Zeinstra
  Address Department of General Practice, room Ff320
Erasmus MC
PO Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Tel +31 (0)10 408 7633
  Fax +31 (0)10 408 9491
  Email s.bierma-zeinstra@erasmusmc.nl
Sponsor Erasmus Medical Centre (The Netherlands)
  Address Board of Directors
PO Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Tel +31 (0)10 463 2578
  Fax +31 (0)10 463 2583
  Email c.festen@erasmusmc.nl
Date applied 14/01/2005
Last edited 22/02/2008
Date ISRCTN assigned 08/03/2005
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