Estimation of Off-Label Use of XGEVA® (denosumab) Using Population-Based Databases in Denmark (20101335)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20211
• EU PAS number:
  EUPAS5687
• Study ID:
  20211
• Official title and acronym:
  Estimation of Off-Label Use of XGEVA® (denosumab) Using Population-Based Databases in Denmark (20101335)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region of Denmark. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 15/11/2012

Study start date

Actual: 24/01/2013

Date of final study report

Actual: 03/11/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.20.01 Protocol Amend 2 2014-07-28 English

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)