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

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bazedoxifene; Diphosphonates; Raloxifene Hydrochloride

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.