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

Pfizer

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Raloxifene; Drug: Bisphosphonate; Drug: Bazedoxifene

Study type: Observational

Funder types: Industry

Identifiers

NCT01416194

B1781044

Details and patient eligibility

About

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.

Full description

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

Enrollment: 10,497 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10,497 participants in 3 patient groups

Bazedoxifene

Treatment:

Drug: Bazedoxifene

Primary Comparator

Treatment:

Drug: Bisphosphonate

Secondary Comparator

Treatment:

Drug: Raloxifene