Cohort Study of Venous Thromboembolism and Other Clinical Endpoints among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates or Raloxifene in Europe

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38352
• EU PAS number:
  EUPAS5395
• Study ID:
  38352
• Official title and acronym:
  Cohort Study of Venous Thromboembolism and Other Clinical Endpoints among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates or Raloxifene in Europe
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Spain
• Study status:
  Finalised

Research institutions and networks

Institutions

Cegedim Health Data (CHD)

France

Study timelines

Date when funding contract was signed

Actual: 15/09/2011

Study start date

Actual: 01/01/2012

Data analysis start date

Planned: 30/04/2019

Date of interim report, if expected

Planned: 30/04/2016

Actual: 22/04/2016

Date of final study report

Planned: 30/04/2020

Actual: 30/04/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

BZA EU PASS_Final_AUG 2013 GDMS_clean

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)