A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT)
| ISRCTN | ISRCTN82719233 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82719233 |
| EudraCT/CTIS number | 2006-002732-22 |
| Secondary identifying numbers | CL3-12911-019 |
- Submission date
- 03/03/2006
- Registration date
- 31/03/2006
- 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 René Rizzoli
Scientific
Scientific
Hôpital Cantonal de Genève
Département de Réhabilitation et Gériatrie
Service des Maladies Osseuses
24, Rue Michelidu-Crest
Geneve 14
1211
Switzerland
Study information
| Study design | Double-blind randomised 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 | A double-blind, multicentric, multinational randomised study to assess the effects of one year administration of 2 g per day of strontium ranelate versus marketed bisphosphonates in women with postmenopausal osteoporosis on bone microarchitecture as measured by high-resolution peripheral-quantitative computed tomography (p-QCT) |
| Study objectives | To demonstrate the effects of strontium ranelate on bone microarchitecture in women with postmenopausal osteoporosis in comparison with marketed bisphosphonates. On 27/11/2012 the anticipated end date for this trial was updated from 31/10/2007 to 28/02/2008. |
| Ethics approval(s) | First Ethics Committee approval obtained on 21/09/2005 in France, ref: 2005-064-2 |
| Health condition(s) or problem(s) studied | Post-menopausal osteoporosis |
| Intervention | Strontium ranelate (S12911) versus marketed bisphosphonates. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bisphosphonates, strontium ranelate |
| Primary outcome measure | Assessment of trabecular bone volume to tissue volume |
| Secondary outcome measures | Assessment of bone density, bone structure and bone markers |
| Overall study start date | 31/10/2005 |
| Completion date | 28/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 72 |
| Key inclusion criteria | 1. Women of at least 50 years old 2. Postmenopausal for at least five years 3. Osteoporosis |
| Key exclusion criteria | 1. Body mass index (BMI) <18 or >30 kg/m^2 2. Skeletal disease 3. Severe malabsorption 4. Significant and evolutive hyperthyroidism |
| Date of first enrolment | 31/10/2005 |
| Date of final enrolment | 28/02/2008 |
Locations
Countries of recruitment
- Australia
- France
- Germany
- Switzerland
Study participating centre
Hôpital Cantonal de Genève
Geneve 14
1211
Switzerland
1211
Switzerland
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 | 01/08/2010 | 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 added.
