The efficacy and safety of two doses of strontium ranelate versus placebo, administered orally for three years in the treatment of knee osteoarthritis
| ISRCTN | ISRCTN41323372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41323372 |
| EudraCT/CTIS number | 2005-002494-75 |
| Secondary identifying numbers | CL3-12911-018 |
- Submission date
- 05/05/2006
- Registration date
- 13/06/2006
- Last edited
- 18/04/2018
- 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 Cyrus Cooper
Scientific
Scientific
University of Southampton
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Prospective multicentre international double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The efficacy and safety of two doses of strontium ranelate (1g and 2g per day) versus placebo administered orally for 3 years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study. |
| Study objectives | To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over three years in men and women with knee osteoarthritis Please note, as of 01/03/2011 the following updates have been made to this record: 1. The anticipated end date for this trial has been moved from 15/04/2009 to 30/03/2011 2. The public title has been updated. The previous title was 'The efficacy and safety of two doses of strontium ranelate versus placebo, administered orally for two years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study'. 3. The study hypothesis has been updated. The previous hypothesis was 'To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over two years in men and women with knee osteoarthritis'. 4. The target number of participants has been increased from 960 to 1680. |
| Ethics approval(s) | First ethics committee approval given by the Ethical Committee of the Ospitalieri Institute of Verona on 14/12/2005, reference number: 1260) |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Strontium ranelate versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure | Radiographic assessment of knee osteoarthritis |
| Secondary outcome measures | 1. Algofunctional assessment 2. Physical examination 3. Safety |
| Overall study start date | 15/04/2006 |
| Completion date | 30/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Added 01/03/2011: 1680 (960 at time of registration) |
| Key inclusion criteria | 1. Caucasian men and women of at least 50 years of age 2. Primary knee osteoarthritis 3. Under effective contraceptive method for non-menopausal women |
| Key exclusion criteria | 1. Knee prosthesis already implanted or foreseen within the next year 2. Hip prosthesis recently implanted (<1 year) or not well-tolerated, or foreseen within the next year |
| Date of first enrolment | 15/04/2006 |
| Date of final enrolment | 30/03/2011 |
Locations
Countries of recruitment
- Australia
- Austria
- Belgium
- Canada
- Czech Republic
- Denmark
- England
- Estonia
- France
- Germany
- Italy
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Russian Federation
- Spain
- United Kingdom
Study participating centre
University of Southampton
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current version as of 28/03/2018: Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature. 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. Previous version as of 24/01/2018: Publication plan: All phases - Interventional studies ending before 01/10/2018: Summary results will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. All phases - Interventional studies ending after 01/10/2018: Summary results and a lay summary will be published on https://clinicaltrials.servier.com/ within 12 months after the end of the study. Phase 3 only - The results will be published in scientific literature within 18 months after the end of the study. |
| 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 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/02/2013 | Yes | No | |
| Results article | results | 01/08/2014 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No |
Editorial Notes
18/04/2018: Internal review
28/03/2018: The publication and dissemination plan has been changed.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary and publication references added.
