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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416194
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal 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.

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Study Type : Observational
Actual Enrollment : 10497 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
Actual Study Start Date : July 25, 2011
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416194


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] August 19, 2013
Statistical Analysis Plan  [PDF] September 27, 2016

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01416194    
Other Study ID Numbers: B1781044
First Posted: August 12, 2011    Key Record Dates
Results First Posted: May 18, 2020
Last Update Posted: May 18, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Bazedoxifene
Diphosphonates
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents