Overview

This trial is active, not recruiting.

Condition osteoporosis, postmenopausal
Treatments bazedoxifene, bisphosphonate, raloxifene
Sponsor Pfizer
Start date July 2011
End date April 2019
Trial size 1 participant
Trial identifier NCT01416194, B1781044

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
bazedoxifene
Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
bisphosphonate
Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
raloxifene
Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Primary Outcomes

Measure
Incidence of venous thromboembolism (VTE)
time frame: During up to 5 years of follow up

Secondary Outcomes

Measure
Incidence of ischemic stroke
time frame: During up to 5 years of follow up
Incidence of thrombotic cardiac disorders
time frame: During up to 5 years of follow up
Incidence of atrial fibrillation
time frame: During up to 5 years of follow up
Incidence of biliary events
time frame: During up to 5 years of follow up
Incidence of hypertriglyceridemia
time frame: During up to 5 years of follow up
Incidence of fracture
time frame: During up to 5 years of follow up
Incidence of chronic renal failure
time frame: During up to 5 years of follow up
Incidence of malignancies
time frame: During up to 5 years of follow up
Incidence of depression
time frame: During up to 5 years of follow up
Incidence of ischemic cardiac disorders
time frame: During up to 5 years of follow up
Incidence of acute renal failure
time frame: During up to 5 years of follow up
Selected ocular events including retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea.
time frame: During up to 5 years
Goiter
time frame: During up to 5 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe
Description All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pfizer.