The Safety and Clinical Effectiveness of Denosumab Among Chinese Men With Osteoporosis – a Real World Study in Taiwan (20210040)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47635
• EU PAS number:
  EUPAS45083
• Study ID:
  47635
• Official title and acronym:
  The Safety and Clinical Effectiveness of Denosumab Among Chinese Men With Osteoporosis – a Real World Study in Taiwan (20210040)
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 18/10/2021

Actual: 18/10/2021

Study start date

Planned: 14/01/2022

Actual: 18/01/2022

Data analysis start date

Planned: 14/01/2022

Actual: 18/01/2022

Date of final study report

Planned: 14/01/2023

Actual: 22/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS45083-45417

Regulatory

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