Status: Finalised First registered on: 27/03/2015
Last updated on: 22/03/2018
1. Study identification
EU PAS Register NumberEUPAS9117
Official titleEuropean Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance
Study title acronym
Study typeOther: Post-Authorization Safety Study (PASS)
Brief description of the studyPASS with a multi-national multi-database approach (population-based cohort study and nested case control analysis in a cohort of new users of strontium ranelate (SR) or oral bisphosphonates) and with the following objectives: 1. To study the effectiveness of the newly established risk minimization measures by characterizing utilization patterns of SR and estimating the prevalence of contraindications (CI) and restrictions of indication amongst incident and prevalent SR users. 2. To estimate and compare the incidence rates of cardiac and thromboembolic events in new users of SR and new users of bisphosphonates.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research group
Organisation/affiliationPrimary Care Research Institute Jordi Gol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Prieto-Alhambra
First name Daniel
Is this study being carried out with the collaboration of a research network?
Yes
EU-ADR Alliance
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

IDIAPJGol
Aarhus University Dept. of Clinical Epidemiology
Health Search-SIMG
Erasmus MC Pharmacoepi
Countries in which this study is being conducted
International study

Denmark
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/201501/04/2015
Start date of data collection01/04/201501/06/2015
Start date of data analysis15/07/2015
Date of interim report, if expected24/11/2015
Date of final study report30/11/201723/11/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLes Laboratoires Servier100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name Bouillant
First name Christine
Address line 150 rue Carnot
Address line 2 
Address line 3 
CitySuresnes 
Postcode 
CountryFrance
Phone number (incl. country code)33155723785 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.bouillant@fr.netgrs.com
Public Enquiries
Title Mrs 
Last name Bouillant 
First name Christine 
Address line 150 rue Carnot 
Address line 2 
Address line 3 
CitySuresnes 
Postcode 
CountryFrance 
Phone number (incl. country code)33155723785 
Alternative phone number 
Fax number (incl. country code) 
Email address christine.bouillant@fr.netgrs.com 
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