Postmarketing Surveillance Study of Prolia (Denosumab) in South Korea

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39173
• EU PAS number:
  EUPAS17915
• Study ID:
  39173
• Official title and acronym:
  Postmarketing Surveillance Study of Prolia (Denosumab) in South Korea
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To estimate the incidence rates of adverse events and change in bone mineral density in patients being treated with Prolia® in a postmarketing setting as required by the Ministry of Food and Drug Safety
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/08/2016

Actual: 29/08/2016

Study start date

Planned: 13/10/2017

Actual: 09/05/2017

Data analysis start date

Planned: 29/09/2019

Actual: 18/05/2020

Date of final study report

Planned: 23/12/2020

Actual: 18/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01 20 01 Protocol Ver 1 0 2016-08-29 redacted

Regulatory

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