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

COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Bazedoxifene; Drug: Bisphosphonate; Drug: Raloxifene

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 10497

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bazedoxifene	Drug: Bazedoxifene; Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Primary Comparator	Drug: Bisphosphonate; Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Secondary Comparator	Drug: Raloxifene; Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incidence of Venous Thromboembolism (VTE)	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.	Up to a maximum of follow-up period of 92.1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incidence of Ischemic Stroke	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Cardiac Disorders	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Atrial Fibrillation	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Biliary Events	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Hypertriglyceridemia	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Clinical Fractures	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Renal Failure	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of All Malignancies	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Different Types of Malignancies	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Depression	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Selected Ocular Events	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.	Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Thyroid Disorders- Goitre	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.	Up to a maximum of follow-up period of 92.1 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2011
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: August 11, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Osteoporosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Raloxifene Hydrochloride; Bazedoxifene; Diphosphonates
• Other Study ID Numbers: B1781044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.