Denosumab Global Safety Assessment in Multiple Observational Databases (20090522)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38617
• EU PAS number:
  EUPAS27559
• Study ID:
  38617
• Official title and acronym:
  Denosumab Global Safety Assessment in Multiple Observational Databases (20090522)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden

  United States
• Study description:
  This is a prospective open-cohort study with annual assessment and reporting of descriptive findings from 5 secondary data sources. The study period will include up to 10 years in each data system.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Aarhus University Hospital

University of Optum Insight USA, University of Alabama at Birmingham USA

Study timelines

Date when funding contract was signed

Actual: 30/12/2009

Study start date

Actual: 26/05/2010

Data analysis start date

Planned: 20/10/2023

Actual: 01/04/2023

Date of interim report, if expected

Planned: 26/11/2019

Actual: 15/05/2019

Date of final study report

Planned: 21/08/2024

Actual: 13/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Updated protocol

Protocol-Published Amendment denosumab 20090522 13 .pdf

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)

Other study registration identification numbers and links

NCT02520362