Postmarketing Surveillance Study of EVENITY (Romosozumab) in South Korea (20170753)

Study identification

• EU PAS number:
  EUPAS30346
• Study ID:
  39019
• Official title and acronym:
  Postmarketing Surveillance Study of EVENITY (Romosozumab) in South Korea (20170753)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned:30/06/2019

Study start date

Planned:25/01/2021

Actual:30/12/2020

Data analysis start date

Planned:31/01/2025

Actual:17/01/2025

Date of interim report, if expected

Planned:31/01/2020

Actual:29/01/2020

Date of final study report

Planned:21/08/2025

Actual:21/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only