CompletedNot Applicable

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

10,497 participantsStarted 2011-07-25

Plain-language summary

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.

Who can participate

Age range45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Cumulative Incidence of Venous Thromboembolism (VTE)

Timeframe: Up to a maximum of follow-up period of 92.1 months

Trial details

NCT IDNCT01416194

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-04-30

Results submitted2020-04-27

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials