Long-term effects of strontium ranelate on knee osteoarthritis symptoms: a two year prospective, randomised, placebo-controlled study
| ISRCTN | ISRCTN33207390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33207390 |
| Protocol serial number | CL3-12911-028 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 29/09/2006
- Registration date
- 12/10/2006
- Last edited
- 28/03/2018
- 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 and not expected to be available in the future
Contact information
Prof JY Reginster
Scientific
Scientific
Policlinique Brull, 45 Quai Godefroid Kurth
Liège
4020
Belgium
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, parallel-group, placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study. |
| Study objectives | To assess the effectiveness on algofunctional symptoms of knee osteoarthritis. Please note that as of 27/11/2012, the anticipated end date was updated from 30/06/2009 to 30/12/2009 |
| Ethics approval(s) | Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité dEthique Hospitalo-Facultaire Universitaire de Liège. |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Strontium ranelate versus placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure(s) |
Changes in the algofunctional behaviour of the target knee. |
| Key secondary outcome measure(s) |
1. Algofunctional assessment |
| Completion date | 30/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 140 |
| Key inclusion criteria | 1. Caucasian males or females 2. Aged 45 years or over 3. Primary knee osteoarthritis 4. Under an effective contraceptive method for non-menopausal women |
| Key exclusion criteria | 1. Knee prosthesis already implanted, or foreseen to be implanted 2. Hip prosthesis already implanted or not well-tolerated or foreseen to be implanted 3. Previous osteotomy on the inferior limbs |
| Date of first enrolment | 30/11/2006 |
| Date of final enrolment | 30/12/2009 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Policlinique Brull, 45 Quai Godefroid Kurth
Liège
4020
Belgium
4020
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
20/12/2017: results summary added.
