Status:
COMPLETED
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
Lead Sponsor:
Pfizer
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
45+ years
Brief 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,...
Detailed Description
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
Eligibility Criteria
Inclusion
- 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
- There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
Key Trial Info
Start Date :
July 25 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
10497 Patients enrolled
Trial Details
Trial ID
NCT01416194
Start Date
July 25 2011
End Date
April 30 2019
Last Update
April 22 2024
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