Status: Ongoing First registered on: 24/09/2020
Last updated on: 29/10/2020
1. Study identification
EU PAS Register NumberEUPAS35881
Official titleEuropean non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance
Study title acronym
Study typeObservational study
Brief description of the studyThe main objective is to evaluate potential differences in terms of serious cardiovascular adverse events between romosozumab and currently available therapies used in comparable patients in real-world conditions.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
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 nameUCB Biosciences GmbH
Centre locationMonheim, Germany
Details of (Primary) lead investigator
Title Dr
Last name Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available.
First name Clinical Trial Registries and Results
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?7

IDIAPJGol
Health Data Science
CPRD
BIPS GmbH
Aarhus University Dept. of Clinical Epidemiology
Health Search-SIMG
Bordeaux PharmacoEpi
Countries in which this study is being conducted
International study

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/09/202030/09/2020
Start date of data collection01/10/202001/10/2020
Start date of data analysis30/09/2026
Date of interim report, if expected
Date of final study report31/03/2027
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesUCB Biopharma SRL100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available.
First name Clinical Trial Registries and Results
Address line 1Alfred-Nobel-Strasse 10
Address line 2 
Address line 3 
CityMonheim 
Postcode40789 
CountryGermany
Phone number (incl. country code)492173481515 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrials@ucb.com
Public Enquiries
Title Dr 
Last name Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available. 
First name Clinical Trial Registries and Results 
Address line 1Alfred-Nobel-Strasse 10 
Address line 2 
Address line 3 
CityMonheim 
Postcode40789 
CountryGermany 
Phone number (incl. country code)492173481515 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrials@ucb.com 
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