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 |
| Protocol serial number | CL3-12911-012 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open international multicentric study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Strontium ranelate |
| Primary outcome measure(s) | 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 |
| Key secondary outcome measure(s) | Safety |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 3000 |
| 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
- United Kingdom
- Australia
- Belgium
- Denmark
- France
- Germany
- Hungary
- Italy
- Poland
- Spain
- Switzerland
Study participating centre
Unité d'Exploration du Métabolisme Osseux
Liege
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 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | 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 reference added.
