Additional identifiers
EudraCT number
2006-005581-39
ClinicalTrials.gov number
Protocol/serial number
CL3-12911-025
Study information
Scientific title
A double-blind, multicentre, international randomised study to assess the effects of 6 months or 12 months administration of strontium ranelate versus biphosphonates on bone remodelling and bone safety assessed by histomorphometry in women with postmenopausal osteoporosis
Acronym
Study hypothesis
To assess the effects of 6 or 12 months treatment of strontium ranelate in comparison with biphosphonates on bone formation assessed by histomorphometry on transiliac paired biopsies performed in patients with postmenopausal osteoporosis treated for one year.
Ethics approval
First Ethics Committee approval obtained on 01/03/2007 in Milan, Italy (ref: 148)
Study design
Double-blind double-dummy randomised controlled study
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
Postmenopausal osteoporosis in women
Intervention
Intervention group: 2 g (one sachet) orally per day of strontium ranelate and one capsule of placebo for 6 or 12 months
Control group: one capsule of bisphosphonates and one sachet of placebo for 6 or 12 months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Histomorphometry on paired transiliac biopsies performed at baseline and after treatment (cancellous mineralising surfaces).
Secondary outcome measures
1. Other histomorphometric parameters
2. Bone markers
Overall trial start date
01/06/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women of at least 50 years of age
2. Postmenopausal for at least three years
3. Osteoporosis
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
285
Participant exclusion criteria
1. Any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure or that potentially could lead to an impossibility to perform a transiliac bone biopsy on each side
2. Previous and concomitant treatments interfering with bone metabolism
Recruitment start date
01/06/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Estonia, Hungary, Italy, Mexico, Poland, United Kingdom
Trial participating centre
INSERM Unité 831
Lyon
69437
France
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
Publication 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
Results - basic reporting
http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-025_synopsis_report.pdf
Publication summary