COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
Overview
- Phase
- Not Applicable
- Intervention
- Raloxifene
- Conditions
- Osteoporosis, Postmenopausal
- Sponsor
- Pfizer
- Enrollment
- 10497
- Primary Endpoint
- Cumulative Incidence of Venous Thromboembolism (VTE)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Arms & Interventions
Secondary Comparator
Intervention: Raloxifene
Bazedoxifene
Intervention: Bazedoxifene
Primary Comparator
Intervention: Bisphosphonate
Outcomes
Primary Outcomes
Cumulative Incidence of Venous Thromboembolism (VTE)
Time Frame: 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 Outcomes
- Cumulative Incidence of Cardiac Disorders(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Atrial Fibrillation(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Hypertriglyceridemia(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Renal Failure(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Ischemic Stroke(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Depression(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Thyroid Disorders- Goitre(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Biliary Events(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Clinical Fractures(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of All Malignancies(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Selected Ocular Events(Up to a maximum of follow-up period of 92.1 months)
- Cumulative Incidence of Different Types of Malignancies(Up to a maximum of follow-up period of 92.1 months)