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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416194
• Other study ID #: B1781044
• Status: Completed
• Start date: July 25, 2011
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10497
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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