Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

• Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of thrombotic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of chronic renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Selected ocular events including retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. [ Time Frame: During up to 5 years ] [ Designated as safety issue: Yes ]
• Goiter [ Time Frame: During up to 5 years ] [ Designated as safety issue: Yes ]

• Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of thrombotic and ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of chronic and acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
• Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]

This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.

All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.

Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.

• Drug: Bazedoxifene
  Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
• Drug: Bisphosphonate
  Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
• Drug: Raloxifene
  Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

• Bazedoxifene
  Intervention: Drug: Bazedoxifene
• Primary Comparator
  Intervention: Drug: Bisphosphonate
• Secondary Comparator
  Intervention: Drug: Raloxifene

Inclusion Criteria:

• Female
• At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
• A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
• Age >=45 at the date of the index prescription; and
• At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription

Exclusion Criteria:

• There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.