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Completed

NCT Number: NCT01416194

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

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bazedoxifene

Drug

Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Bisphosphonate

Drug

Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Raloxifene

Drug

Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Primary outcomes

  1. 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

  1. Cumulative Incidence of Ischemic Stroke

    Time frame: 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.

  2. Cumulative Incidence of Cardiac Disorders

    Time frame: 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.

  3. Cumulative Incidence of Atrial Fibrillation

    Time frame: 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.

  4. Cumulative Incidence of Biliary Events

    Time frame: 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.

  5. Cumulative Incidence of Hypertriglyceridemia

    Time frame: 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.

  6. Cumulative Incidence of Clinical Fractures

    Time frame: 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.

  7. Cumulative Incidence of Renal Failure

    Time frame: 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.

  8. Cumulative Incidence of All Malignancies

    Time frame: 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.

  9. Cumulative Incidence of Different Types of Malignancies

    Time frame: 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.

  10. Cumulative Incidence of Depression

    Time frame: 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.

  11. Cumulative Incidence of Selected Ocular Events

    Time frame: 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.

  12. Cumulative Incidence of Thyroid Disorders- Goitre

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2011
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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