Post-marketing Study Assessing the Serious Cardiovascular Events Among Osteoporotic Patients Initiating Romosozumab in Japan Using the Medical Information Database Network (MID-NET) (20190206)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000308
• EU PAS number:
  EUPAS1000000308
• Study ID:
  1000000308
• Official title and acronym:
  Post-marketing Study Assessing the Serious Cardiovascular Events Among Osteoporotic Patients Initiating Romosozumab in Japan Using the Medical Information Database Network (MID-NET) (20190206)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 07/06/2024

Actual: 07/06/2024

Study start date

Planned: 01/11/2024

Actual: 23/12/2024

Data analysis start date

Planned: 01/04/2026

Date of final study report

Planned: 01/12/2026

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Initial protocol

Protocol-Published Original romosozumab 20190206.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