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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-25

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Bazedoxifene

Intervention Type DRUG

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

Primary Comparator

Bisphosphonate

Intervention Type DRUG

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

Secondary Comparator

Raloxifene

Intervention Type DRUG

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

Interventions

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Bazedoxifene

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

Intervention Type DRUG

Bisphosphonate

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

Intervention Type DRUG

Raloxifene

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No