Status: Planned First registered on: 13/07/2019
Last updated on: 02/06/2020
1. Study identification
EU PAS Register NumberEUPAS30506
Official titleOsteoporosis outcomes and treatment patterns in France (20190017)
Study title acronym
Study typeObservational study
Brief description of the studyThis is a retrospective cohort study in the National healthcare data system (Système National des Données de Santée - SNDS) containing French nationwide claims and hospital database including postmenopausal women receiving treatment for osteoporosis. The research question is to assess the treatment patterns and the impact of osteoporosis medication on fracture incidence in France. The primary objective is to assess the change in fracture risk after treatment initiation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type of treatment and type of fracture
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
Yes
Bordeaux PharmacoEpi
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/06/201928/06/2019
Start date of data collection15/06/2020
Start date of data analysis01/08/2020
Date of interim report, if expected
Date of final study report30/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com
Public Enquiries
Title Dr 
Last name Amgen Inc. 
First name Global Development Leader 
Address line 1One Amgen Center Drive 
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States 
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com 
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