SOTI and TROPOS phase III studies open-label extension. The long term efficacy and long term safety assessment of a five-year oral administration of strontium ranelate in osteoporotic postmenopausal women having participated either in Spinal Osteoporosis Therapeutic Intervention "SOTI" study or TReatment Of Peripheral OSteoporosis "TROPOS" study. A five-year multicentric multinational open study with strontium ranelate.
| ISRCTN | ISRCTN48348637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48348637 |
| Secondary identifying numbers | CL3-12911-012 |
- Submission date
- 05/09/2007
- Registration date
- 16/05/2008
- 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 J Y Reginster
Scientific
Scientific
Unité d'Exploration du Métabolisme Osseux
CHU BRULL
45, Quai Godefroid Kurth
Liege
4020
Belgium
Study information
| Study design | Open international multicentric study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | SOTI and TROPOS phase III studies open-label extension. The long term efficacy and long term safety assessment of a five-year oral administration of strontium ranelate in osteoporotic postmenopausal women having participated either in Spinal Osteoporosis Therapeutic Intervention "SOTI" study or TReatment Of Peripheral OSteoporosis "TROPOS" study. A five-year multicentric multinational open study with strontium ranelate. |
| Study objectives | 1. To assess the efficacy of an additional 5-year oral administration of strontium ranelate on bone mineral density (BMD), on the number of patients experiencing new osteoporotic fractures on body height and on bone markers in the SOTI and TROPOS patients having already received active treatment for 4 or 5 years 2. To allow patients treated with placebo in the main part of the SOTI study or for 5 years in the TROPOS study to receive active treatment for a duration known to be effective on vertebral fractures 3. To assess the safety of an additional 5-year oral administration of strontium ranelate in SOTI and TROPOS patients having already received active treatment for 4 or 5 years 4. To assess the safety of a 5-year oral administration of strontium ranelate in SOTI and TROPOS patients treated with placebo in the main part of the SOTI or TROPOS studies |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Postmenopausal osteoporosis |
| Intervention | All participants will take 2 g per day of strontium ranelate for five years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure | The following will be assessed annually during the treatment: 1. Dual X-ray absorptiometry (DXA) 2. Vertebral fractures radiographs in patients having had vertebral radiographs in SOTI or TROPOS 3. Occurrence of peripheral fractures |
| Secondary outcome measures | Safety |
| Overall study start date | 09/09/2002 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 3,000 |
| Key inclusion criteria | 1. Caucasian women 2. Postmenopausal 3. Osteoporosis 4. Having participated up to the SOTI or TROPOS M060 visit or withdrawn under study treatment from the SOTI or TROPOS study within a 6-month period preceding the theoretical M060 visit |
| Key exclusion criteria | 1. Patients having attended the M060 or withdrawn SOTI-TROPOS visit at a time greater than one year prior to the inclusion visit of the CL3-12911-012 protocol 2. Significant concomitant disease (evolutive major illnesses) 3. Severe disease interfering with bone metabolism |
| Date of first enrolment | 09/09/2002 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Australia
- Belgium
- Denmark
- France
- Germany
- Hungary
- Italy
- Poland
- Spain
- Switzerland
- United Kingdom
Study participating centre
Unité d'Exploration du Métabolisme Osseux
Liege
4020
Belgium
4020
Belgium
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 | 01/03/2012 | 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 reference added.
