EVENITY® Risk Minimisation Materials Effectiveness Measurement in Australia (20220120)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106263
• EU PAS number:
  EUPAS104308
• Study ID:
  106263
• Official title and acronym:
  EVENITY® Risk Minimisation Materials Effectiveness Measurement in Australia (20220120)
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Study to measure the effectiveness of educational materials on awareness, utilization and adequacy targeted to medical professionals in addressing the cardiovascular risks associated with the use of EVENITY.
• Study status:
  Finalised

Research institution and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 01/12/2022

Actual: 01/12/2022

Study start date

Planned: 01/03/2023

Actual: 04/04/2023

Data analysis start date

Planned: 01/05/2023

Actual: 01/05/2023

Date of final study report

Planned: 15/04/2024

Actual: 03/04/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original romosozumab 20220120 (1).pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)