Study identification

PURI

https://redirect.ema.europa.eu/resource/37816

EU PAS number

EUPAS36005

Study ID

37816

Official title and acronym

EUROPEAN NON-INTERVENTIONAL POST AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU ADR ALLIANCE

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

The overarching objective of this study is to monitor the potential risk of serious infection associated with the use of romosozumab in comparison with other available osteoporosis medications in routine clinical practice in Europe

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

op0006-protocol-final-Redacted

English (1.36 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)