Incidence of Cardiovascular and Cerebrovascular Events Among Postmenopausal Women and Men With Osteoporosis Who Initiated Treatment With Denosumab or Zoledronic Acid - A Retrospective Cohort Study (20190038)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42980
• EU PAS number:
  EUPAS32133
• Study ID:
  42980
• Official title and acronym:
  Incidence of Cardiovascular and Cerebrovascular Events Among Postmenopausal Women and Men With Osteoporosis Who Initiated Treatment With Denosumab or Zoledronic Acid - A Retrospective Cohort Study (20190038)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 22/10/2019

Actual: 22/10/2019

Study start date

Planned: 27/03/2020

Actual: 27/03/2020

Data analysis start date

Planned: 14/09/2020

Actual: 14/09/2020

Date of final study report

Planned: 14/09/2021

Actual: 24/08/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

20190038_01.02.06 Public Redacted Protocol Ver 1.0 2019-09-25 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)