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

NCT01416194 | Completed Results

• 1 other identifier: B1781044
• Study Type: observational
• Target: 10,497
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis, Postmenopausal

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Cumulative Incidence of Ischemic Stroke

  Up to a maximum of follow-up period of 92.1 months

• 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 Biliary Events

  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

Study Arms (3)

Bazedoxifene

Drug: Bazedoxifene

Primary Comparator

Drug: Bisphosphonate

Secondary Comparator

Drug: Raloxifene

Interventions

Bazedoxifene DRUG

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

Bazedoxifene

Bisphosphonate DRUG

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

Primary Comparator

Raloxifene DRUG

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

Secondary Comparator

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female
• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

bazedoxifene; Diphosphonates; Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: July 25, 2011
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: April 22, 2024
• Results First Posted: May 18, 2020

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share