Condition category
Musculoskeletal Diseases
Date applied
14/01/2005
Date assigned
08/03/2005
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sita M.A. Bierma-Zeinstra

ORCID ID

Contact details

Department of General Practice
room Ff320
Erasmus MC
PO Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 7633
s.bierma-zeinstra@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GOAL

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.

Ethics approval

Trial approved by the Medical Ethics Committee at the Erasmus MC - University Medical Centre Rotterdam.

Study design

Randomised, blinded, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis

Intervention

Patients are randomised to either 1500 mg of oral glucosamine sulphate or a placebo daily for the duration of two years.

Intervention type

Drug

Phase

Not Specified

Drug names

Glucosamine

Primary outcome measures

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 measures

Secondary outcome measures are changes in WOMAC stiffness score, quality of life, medical consumption, side effects and differences in biomarker CTX-II.

Overall trial start date

01/10/2003

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients are eligible for participation when they meet one of the American College of Rheumatology (ACR) criteria for osteoarthritis of the hip.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

222

Participant 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

Recruitment start date

01/10/2003

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of General Practice, room Ff320
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Board of Directors
PO Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 2578
c.festen@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands) - Breedtestrategie

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Study protocol in http://www.ncbi.nlm.nih.gov/pubmed/15850497
2. Results in http://www.ncbi.nlm.nih.gov/pubmed/18283204

Publication citations

  1. Study protocol

    Rozendaal RM, Koes BW, Weinans H, Uitterlinden EJ, van Osch GJ, Ginai AZ, Verhaar JA, Bierma-Zeinstra SM, The effect of glucosamine sulphate on osteoarthritis: design of a long-term randomised clinical trial [ISRCTN54513166]., BMC Musculoskelet Disord, 2005, 6, 20, doi: 10.1186/1471-2474-6-20.

  2. Results

    Rozendaal RM, Koes BW, van Osch GJ, Uitterlinden EJ, Garling EH, Willemsen SP, Ginai AZ, Verhaar JA, Weinans H, Bierma-Zeinstra SM, Effect of glucosamine sulfate on hip osteoarthritis: a randomized trial., Ann. Intern. Med., 2008, 148, 4, 268-277.

Additional files

Editorial Notes