Study identification

PURI

https://redirect.ema.europa.eu/resource/37813

EU PAS number

EUPAS35956

Study ID

37813

Official title and acronym

EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

To study the adherence to the risk minimization measures in the product information by estimating the compliance with contraindications and target indication amongst incident romosozumab users, and analyzing the utilization patterns.

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

op0005-protocol-final-Redacted

English (1.18 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)