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 |
| Clinical Trials Information System (CTIS) | 2005-002494-75 |
| Protocol serial number | CL3-12911-018 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective multicentre international double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure(s) |
Radiographic assessment of knee osteoarthritis |
| Key secondary outcome measure(s) |
1. Algofunctional assessment |
| Completion date | 30/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1680 |
| 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
- United Kingdom
- England
- Australia
- Austria
- Belgium
- Canada
- Czech Republic
- Denmark
- Estonia
- France
- Germany
- Italy
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Russian Federation
- Spain
Study participating centre
University of Southampton
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
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 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2013 | Yes | No | |
| Results article | results | 01/08/2014 | Yes | No | |
| Results article | results | 01/02/2015 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
