Additional identifiers
EudraCT/CTIS number
2006-002732-22
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-019
Study information
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)
Acronym
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
28/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women of at least 50 years old
2. Postmenopausal for at least five years
3. Osteoporosis
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
72
Participant exclusion criteria
1. Body mass index (BMI) <18 or >30 kg/m^2
2. Skeletal disease
3. Severe malabsorption
4. Significant and evolutive hyperthyroidism
Recruitment start date
31/10/2005
Recruitment end date
28/02/2008
Locations
Countries of recruitment
Australia, France, Germany, Switzerland
Study participating centre
Hôpital Cantonal de Genève
Geneve 14
1211
Switzerland
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
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 |