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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39019
• 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:
  Ongoing

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: 28/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Updated protocol

Protocol-Published Superseding romosozumab 20170753 2 .pdf

Regulatory

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