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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Post-authorization safety study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BAZEDOXIFENE

Population studied

• Short description of the study population:
  All women in the Cegedim database meeting the inclusion criteria will be included in the analysis without any sampling process.; Inclusion Criteria; Subjects must meet all of the following inclusion criteria to be eligible for inclusion into the study:; 1. Female; 2. At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);; 3. A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;; 4. Age >=45 at the date of the index prescription; and; 5. At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2150

Study design details

• Main study objective:
  To estimate and compare the incidence rates of venous thromboembolism (VTE) among women receiving bazedoxifene and women receiving a bisphosphonate for treatment of osteoporosis.
• Outcomes:
  Venous thromboembolism (VTE), • Ischemic stroke• Thrombotic and ischemic cardiac disorders (including myocardial infarction, myocardial ischemia, and coronary occlusion)• Atrial fibrillation• Biliary events: cholecystitis, cholelithiasis• Hypertriglyceridemia • Fractures• Chronic and acute renal failure (including chronic renal insufficiency and end stage renal disease)• Malignancies including breast, renal, ovar
• Data analysis plan:
  Incidence rates will be calculated for all endpoints in all treatment groups, incidence rate ratios and 95% confidence intervals will be calculated and compared. Stratifications by risk factors of interest

Documents

Study results

B1781044_Bazedoxifene_Final_Study_Report_ABSTRACT_24April2020 V1

Study report

B1781044_Bazedoxifene_Final_Study_Report_24April2020 V1