A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With
XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway (20101363)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36664
• EU PAS number:
  EUPAS32437
• Study ID:
  36664
• Official title and acronym:
  A Non-interventional Pharmacovigilance Study of Osteonecrosis of the Jaw and Infection Leading to Hospitalization Among Patients With Cancer Treated With XGEVA™ or Zoledronic Acid in Sweden, Denmark, and Norway (20101363)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  This study aims to describe occurrence of two adverse events of special interest (AESIs) related to XGEVA (denosumab) use, osteonecrosis of the jaw (ONJ) and infection leading to hospitalization, in a postmarketing environment. The study was conducted using data linked from nationwide administrative and health registries in Sweden, Denmark, and Norway, in combination with abstraction of data from patients’ medical records. Patients were identified from 01 October 2011 through 31 December 2013 in Sweden and Norway and through 31 December 2014 in Denmark, and eligible patients were included in one of the three treatment cohorts: the XGEVA inception cohort, the zoledronic acid inception cohort, and the XGEVA-switch cohort. Incidence of medically confirmed ONJ and infections leading to hospitalization were estimated for the three treatment cohorts, overall and stratified by primary cancer site, country, and calendar year of index date.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/01/2012

Actual: 01/01/2012

Study start date

Planned: 01/03/2012

Actual: 01/03/2012

Data analysis start date

Planned: 08/06/2019

Actual: 08/06/2019

Date of final study report

Planned: 24/01/2020

Actual: 07/01/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20101363_01.02.06 Public Redacted Protocol Ver 1.0 2016-06-29 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)