Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Registration Number
- NCT01416194
- Lead Sponsor
- Pfizer
- 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, 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.
- Detailed Description
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10497
- 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
- There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bazedoxifene Bazedoxifene - Primary Comparator Bisphosphonate - Secondary Comparator Raloxifene -
- Primary Outcome Measures
Name Time Method Cumulative Incidence of Venous Thromboembolism (VTE) Up to a maximum of follow-up period of 92.1 months VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
- Secondary Outcome Measures
Name Time Method Cumulative Incidence of Cardiac Disorders Up to a maximum of follow-up period of 92.1 months Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Atrial Fibrillation Up to a maximum of follow-up period of 92.1 months Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Hypertriglyceridemia Up to a maximum of follow-up period of 92.1 months Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Renal Failure Up to a maximum of follow-up period of 92.1 months Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Ischemic Stroke Up to a maximum of follow-up period of 92.1 months Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Depression Up to a maximum of follow-up period of 92.1 months Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Thyroid Disorders- Goitre Up to a maximum of follow-up period of 92.1 months Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Biliary Events Up to a maximum of follow-up period of 92.1 months Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Clinical Fractures Up to a maximum of follow-up period of 92.1 months A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of All Malignancies Up to a maximum of follow-up period of 92.1 months All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Selected Ocular Events Up to a maximum of follow-up period of 92.1 months Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence was expressed as percentage of participants.
Cumulative Incidence of Different Types of Malignancies Up to a maximum of follow-up period of 92.1 months In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period\*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants.