Clinical Characteristics, Including History of MI and Stroke, Among US Post-menopausal Women Initiating Treatment With Romosozumab and Other Anti-osteoporosis Therapies (20190205)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37633
• EU PAS number:
  EUPAS37160
• Study ID:
  37633
• Official title and acronym:
  Clinical Characteristics, Including History of MI and Stroke, Among US Post-menopausal Women Initiating Treatment With Romosozumab and Other Anti-osteoporosis Therapies (20190205)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective, repeated analysis design study. Post-menopausal women, aged 55 and above, who have initiated treatment with romosozumab or other anti-osteoporosis medications, will be included in this study. The planned study period is approximately 5 years, made up of four 1-year blocks, one 6-month block and a 6-7 month estimated data-lag. Information will be collected to evaluate the clinical characteristics and pharmacovigilance of romosozumab and other anti-osteoporosis medications in post-menopausal women in the United States.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Networks

PCORnet Clinical Data Research Network (CDRN)

Study timelines

Date when funding contract was signed

Planned: 01/09/2020

Actual: 03/09/2020

Study start date

Planned: 15/09/2020

Actual: 15/09/2020

Data analysis start date

Planned: 28/02/2025

Date of final study report

Planned: 28/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

Protocol-Published Amendment romosozumab 20190205 1 (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

Other study registration identification numbers and links

Protocol number - 20190205