Study identification

PURI

https://redirect.ema.europa.eu/resource/37810

EU PAS number

EUPAS35881

Study ID

37810

Official title and acronym

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

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

The 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.

Study status

Ongoing
Research institution and networks

Institutions

UCB Biosciences
First published:
01/02/2024
Institution

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:

Data collection

Planned:
Actual:

Start date of data analysis

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

op0004-protocol-final-Redacted

English (1.62 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)