Prospective observational study to describe routine use of XGEVAâ for prevention of skeletal related events (SREs) in subjects with bone metastases from prostate carcinoma in Bulgaria (20180095)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48138
• EU PAS number:
  EUPAS26983
• Study ID:
  48138
• Official title and acronym:
  Prospective observational study to describe routine use of XGEVAâ for prevention of skeletal related events (SREs) in subjects with bone metastases from prostate carcinoma in Bulgaria (20180095)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria
• Study description:
  The study will address the question of the use of XGEVAâ for prevention of SREs in subjects with bone metastases from prostate carcinoma in Bulgaria. The primary objective is to describe real life patterns of bone metastases management and routine use of XGEVA® for SREs prevention in subjects with bone metastases from hormone sensitive and castration-resistant prostate carcinoma. The secondary objectives are to estimate the incidence of SREs, healthcare utilization and pain management.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 12/04/2018

Actual: 12/04/2018

Study start date

Planned: 31/05/2019

Actual: 17/05/2019

Data analysis start date

Planned: 29/01/2021

Actual: 31/03/2021

Date of final study report

Planned: 31/08/2022

Actual: 16/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20180095_01.02.06 Public Redacted Protocol Ver 1.0 2018-10-24 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only