Additional identifiers
EudraCT number
2007-001509-11
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-030
Study information
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).
Acronym
Study hypothesis
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
Ethics approval was obtained before recruitment of the first participants
Study design
Randomised double-blind double-dummy trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial 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
2 g strontium ranelate versus bisphosphonate for two years.
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
30/09/2007
Overall trial end date
30/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women of at least 50 years old
2. Post-menopausal for at least 5 years
3. Osteoporosis
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Added 01/03/2011: 148 (80 at time of registration)
Participant 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
Recruitment start date
30/09/2007
Recruitment end date
30/03/2011
Locations
Countries of recruitment
Germany, Greece, Italy, Sweden
Trial participating centre
Charité Campus Benjamin Franklin
Berlin
D-12203
Belgium
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
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
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.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-030_synopsis_report.pdf
Publication list
2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20512336/