Study identification

PURI

https://redirect.ema.europa.eu/resource/23302

EU PAS number

EUPAS9117

Study ID

23302

Official title and acronym

European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance

DARWIN EU® study

No

Study countries

Denmark
Italy
Netherlands
Spain
United Kingdom

Study description

PASS with a multi-national multi-database approach (population-based cohort study and nested case control analysis in a cohort of new users of strontium ranelate (SR) or oral bisphosphonates) and with the following objectives:1. To study the effectiveness of the newly established risk minimization measures by characterizing utilization patterns of SR and estimating the prevalence of contraindications (CI) and restrictions of indication amongst incident and prevalent SR users. 2. To estimate and compare the incidence rates of cardiac and thromboembolic events in new users of SR and new users of bisphosphonates.

Study status

Finalised
Research institution and networks

Institutions

Networks

Contact details

Daniel Prieto-Alhambra

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Actual:

Date of interim report, if expected

Actual:

Date of final study report

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

More details on funding

Les Laboratoires Servier
Study protocol
Initial protocol

2015_01_07_EU ADR Alliance SR protocol_final_clean_redacted

English (1.61 MB - PDF)View document
Updated protocol

2017_04_28_EU ADR Alliance SR protocol_final_Updated_April_2017_clean_redacted

English (2.18 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 1 (imposed as condition of marketing authorisation)