A two-stage, prospective observational study describing the use and effectiveness of XGEVA®/ANJIAWEI® for the prevention of skeletal related events in patients with bone metastases from solid tumors relative to ZOMETA® in the People's Republic of China (20190036)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105058
• EU PAS number:
  EUPAS104114
• Study ID:
  105058
• Official title and acronym:
  A two-stage, prospective observational study describing the use and effectiveness of XGEVA®/ANJIAWEI® for the prevention of skeletal related events in patients with bone metastases from solid tumors relative to ZOMETA® in the People's Republic of China (20190036)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 15/08/2020

Actual: 15/08/2020

Study start date

Planned: 29/02/2024

Actual: 05/03/2024

Data analysis start date

Planned: 05/03/2029

Date of final study report

Planned: 19/07/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen, Inc.

Study protocol

Initial protocol

Protocol-Published Original denosumab 20190036 .pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable