Glucosamine in osteoarthritis: long-term effectiveness

ISRCTN	ISRCTN54513166
DOI	https://doi.org/10.1186/ISRCTN54513166
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands) - Breedtestrategie

Submission date: 14/01/2005
Registration date: 08/03/2005
Last edited: 22/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sita M.A. Bierma-Zeinstra
Scientific

Department of General Practice, room Ff320
Erasmus MC
PO Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 408 7633
Email	s.bierma-zeinstra@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised, blinded, placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	GOAL
Study objectives	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(s)	Trial approved by the Medical Ethics Committee at the Erasmus MC - University Medical Centre Rotterdam.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Glucosamine
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.
Key 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.
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	222
Key inclusion criteria	Patients are eligible for participation when they meet one of the American College of Rheumatology (ACR) criteria for osteoarthritis of the hip.
Key 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
Date of first enrolment	01/10/2003
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of General Practice, room Ff320

Rotterdam
3000 CA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	19/02/2008		Yes	No
Protocol article	Study protocol	26/04/2005		Yes	No