A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus bisphosphonate in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT)
| ISRCTN | ISRCTN10335153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10335153 |
| EudraCT/CTIS number | 2007-001509-11 |
| Secondary identifying numbers | CL3-12911-030 |
- Submission date
- 28/08/2007
- Registration date
- 17/09/2007
- Last edited
- 28/03/2018
- 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 Dieter Felsenberg
Scientific
Scientific
Charité Campus Benjamin Franklin
Klinik und Poliklinik für Radiologie und Nuklearmedizin
Berlin
D-12203
Belgium
Study information
| Study design | Randomised double-blind double-dummy trial |
|---|---|
| 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 two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT). |
| Study objectives | Current hypothesis as of 03/03/2011: To assess the effects of strontium ranelate in comparison with bisphophonate on cortical thickness, the bone geometrical parameters and bone strength in patients with postmenopausal osteoporosis Previous hypothesis: To assess the effects of strontium ranelate in comparison with bisphosphonate on the bone geometry and bone strength in patients with postmenopausal osteoporosis. Please note, as of 01/03/2011 the following updates have been made to this record: - The anticipated end date has been updated from 30/09/2010 to 30/03/2011. - The target number of participants has been increased from 80 to 148. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Post-menopausal osteoporosis |
| Intervention | 2 g strontium ranelate versus bisphosphonate for two years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Strontium ranelate, bisphosphonate |
| Primary outcome measure | Current primary outcome measure(s) as of 01/03/2011: Cortical thickness measured every 6 months from baseline to M024 Previous primary outcomes measure(s): Geometrical and bone strength parameters, measured at baseline and 2 years. |
| Secondary outcome measures | Current secondary outcome measure(s) as of 01/03/2011: 1. Geometrical and bone strength parameters 2. Bone Mineral Density (BMD) 3. Bone markers Main secondary outcome measure timepoints are at baseline, M012, M024 Previous secondary outcome measures(s): 1. Bone content 2. Bone density 3. Bone Mineral Density (BMD) 4. Bone markers Main secondary outcome measure timepoints are at baseline and 2 years. |
| Overall study start date | 30/09/2007 |
| Completion date | 30/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Added 01/03/2011: 148 (80 at time of registration) |
| Key inclusion criteria | 1. Women of at least 50 years old 2. Post-menopausal for at least 5 years 3. Osteoporosis |
| Key exclusion criteria | 1. Evolutive cancer during the past 5 years with a risk of bone metastases 2. Body Mass Index less than 18 or greater than 30 kg/m^2 3. Severe malabsorption |
| Date of first enrolment | 30/09/2007 |
| Date of final enrolment | 30/03/2011 |
Locations
Countries of recruitment
- Belgium
- Germany
- Greece
- Italy
- Sweden
Study participating centre
Charité Campus Benjamin Franklin
Berlin
D-12203
Belgium
D-12203
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 | Summary results are published on https://clinicaltrials.servier.com. |
| 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. |
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
24/01/2018: Publication plan and IPD sharing statement amended.
11/12/2017: results summary and publication reference added.
