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

CompletedN/A

Sponsor: Pfizer

Conditions: Osteoporosis, Postmenopausal

Interventions: Bazedoxifene, Bisphosphonate, Raloxifene

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.

Eligibility overview

Sex: FEMALE

Age: 45 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.