Status: Ongoing First registered on: 12/08/2020
Last updated on: 29/10/2020
1. Study identification
EU PAS Register NumberEUPAS36734
Official titleVALIDATION STUDY PROTOCOL (OP0007) FOR THE EUROPEAN 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 (OP0004) AND EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0006)
Study title acronym
Study typeOther: Outcome validation study for real-world data
Brief description of the studyThe objective of this study is to determine the completeness and diagnostic validity of the following outcomes, which will be evaluated in the 2 European non-interventional post-authorisation safety studies (PASS) of romosozumab: 1. cardiovascular death; 2. myocardial infarction; 3. Stroke; 4. serious infection. Outcomes will be identified based on predefined code lists, which were adapted according to the relevant coding system for the respective database. Validation algorithms are defined individually for each specific outcome. In addition, the validation procedures, e.g. manual free text evaluation, will depend on the specific characteristics of the individual databases (primary care and claims databases). Validation of the outcomes of interest will be conducted for databases where previous validation demonstrated insufficient positive predictive values (PPVs) <75% (all-case validation), or where validation has not yet been performed (sample validation of 250 cases).
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 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?5

IDIAPJGol
Health Data Sciences
CPRD
BIPS GmbH
Health Search-SIMG
Countries in which this study is being conducted
International study

Germany
Italy
Netherlands
Spain
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 2Not applicable 
Address line 3Not applicable 
CityMonheim 
Postcode 
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 2Not applicable 
Address line 3Not applicable 
CityMonheim 
Postcode 
CountryGermany 
Phone number (incl. country code)492173481515 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrials@ucb.com 
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