The use and safety of XGEVA or Zoledronic acid in clinical practice among Chinese patients with bone metastases from breast, lung, or prostate cancer – a retrospective cohort study within Taiwan’s Health Insurance Research Database (20190412)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46008
• EU PAS number:
  EUPAS39611
• Study ID:
  46008
• Official title and acronym:
  The use and safety of XGEVA or Zoledronic acid in clinical practice among Chinese patients with bone metastases from breast, lung, or prostate cancer – a retrospective cohort study within Taiwan’s Health Insurance Research Database (20190412)
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study description:
  This study is a retrospective cohort study aiming to describe the utilization of XGEVA and Zoledronic acid and to characterize the safety of XGEVA among Chinese patients with breast, lung, or prostate cancer following diagnosis of incident bone metastases (BMs). The study population will include patients in Taiwan's National Health Insurance (NHI) Database who were diagnosed with bone metastasis secondary to breast, lung or prostate cancer and were newly treated with XGEVA or Zoledronic acid.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 15/03/2021

Actual: 25/02/2021

Study start date

Planned: 31/05/2021

Actual: 06/04/2021

Data analysis start date

Planned: 17/01/2022

Actual: 17/01/2022

Date of final study report

Planned: 17/01/2023

Actual: 24/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS39611-40005

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable