Glucosamine in osteoarthritis: long-term effectiveness
| ISRCTN | ISRCTN54513166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54513166 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Sita M.A. Bierma-Zeinstra
Scientific
Scientific
Department of General Practice, room Ff320
Erasmus MC
PO Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 408 7633 |
|---|---|
| s.bierma-zeinstra@erasmusmc.nl |
Study information
| Study design | Randomised, blinded, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Trial approved by the Medical Ethics Committee at the Erasmus MC - University Medical Centre Rotterdam. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glucosamine |
| Primary outcome measure | 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 study start date | 01/10/2003 |
| Overall study end date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 222 |
| 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 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
Study participating centre
Department of General Practice, room Ff320
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Board of Directors
PO Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 2578 |
|---|---|
| c.festen@erasmusmc.nl | |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands) - Breedtestrategie
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Study protocol | 26/04/2005 | Yes | No | |
| Results article | Results | 19/02/2008 | Yes | No |
