The Incidence and Risk factors for Hypocalcaemia Among Osteoporosis Patients Receiving Romosozumab or Other Antiresorptive Therapy in Japan -- A Retrospective Cohort Study Within the Medical Information Database Network (MID-NET)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000055
• EU PAS number:
  EUPAS1000000055
• Study ID:
  1000000055
• Official title and acronym:
  The Incidence and Risk factors for Hypocalcaemia Among Osteoporosis Patients Receiving Romosozumab or Other Antiresorptive Therapy in Japan -- A Retrospective Cohort Study Within the Medical Information Database Network (MID-NET)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study status:
  Planned

Research institutions and networks

Institutions

Amgen

United States

Networks

Medical Information Database Network (MID-NET)

Study timelines

Date when funding contract was signed

Planned: 16/05/2024

Study start date

Planned: 01/06/2024

Data analysis start date

Planned: 01/02/2026

Date of final study report

Planned: 30/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen 100%

Study protocol

Initial protocol

Protocol-Published Amendment romosozumab 20190207 2 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

20190207