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

24/09/2020
09/01/2026
EU PAS number:
EUPAS36005
Study
Finalised
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Study identification

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

Finalised
Research institutions and networks

Institutions

UCB Biopharma SRL
Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner

Networks

Contact details

Clinical Trial Registries and Results

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:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

UCB Biopharma SRL
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)