Study identification

PURI

https://redirect.ema.europa.eu/resource/37819

EU PAS number

EUPAS36734

Study ID

37819

Official title and acronym

VALIDATION 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)

DARWIN EU® study

No

Study countries

Germany
Italy
Netherlands
Spain

Study description

The 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).

Study status

Ongoing
Research institution and networks

Institutions

UCB Biopharma SRL
Teamit Institute
Spain
First published:
12/03/2024
InstitutionOtherENCePP partner

Networks

Contact details

Clinical Trial Registries and Results | 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.

Study contact
clinicaltrials@ucb.com

Clinical Trial Registries and Results | 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.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

UCB Biopharma SRL
Study protocol
Initial protocol

op0007-protocol-final-Redacted

English (2.5 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable