Trial Outcomes & Findings for Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU) (NCT NCT01416194)

NCT ID: NCT01416194

Last Updated: 2024-04-22

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 10497 participants
• Primary outcome timeframe: Up to a maximum of follow-up period of 92.1 months
• Results posted on: 2024-04-22

Participant Flow

This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD).

The index date for each participant was the date of first recorded prescription for bazedoxifene, raloxifene or bisphosphonate. Follow-up period was from index date to first incident of primary event or date of last contact, whichever occurred first. Follow-up was maximum up to approximately of 92.1 months.

Participant milestones

Measure	Bazedoxifene Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per summary of product characteristics (SmPC) and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Overall Study STARTED	1111	2720	6666
Overall Study COMPLETED	1111	2720	6666
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Total n=10497 Participants Total of all reporting groups
Age, Customized From 45-49 years	51 Participants n=1111 Participants	78 Participants n=2720 Participants	88 Participants n=6666 Participants	217 Participants n=10497 Participants
Age, Customized From 50-59 years	479 Participants n=1111 Participants	665 Participants n=2720 Participants	915 Participants n=6666 Participants	2059 Participants n=10497 Participants
Age, Customized From 60-69 years	382 Participants n=1111 Participants	1229 Participants n=2720 Participants	1915 Participants n=6666 Participants	3526 Participants n=10497 Participants
Age, Customized From greater than equal to (>=) 70 years	199 Participants n=1111 Participants	748 Participants n=2720 Participants	3748 Participants n=6666 Participants	4695 Participants n=10497 Participants
Sex: Female, Male Female	1111 Participants n=1111 Participants	2720 Participants n=2720 Participants	6666 Participants n=6666 Participants	10497 Participants n=10497 Participants
Sex: Female, Male Male	0 Participants n=1111 Participants	0 Participants n=2720 Participants	0 Participants n=6666 Participants	0 Participants n=10497 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Venous Thromboembolism (VTE)	1.5 percentage of participants Interval 1.0 to 2.4	2.2 percentage of participants Interval 1.7 to 2.8	4.6 percentage of participants Interval 4.1 to 5.1

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Ischemic Stroke	2.2 percentage of participants Interval 1.5 to 3.2	2.6 percentage of participants Interval 2.1 to 3.3	6.7 percentage of participants Interval 6.2 to 7.4

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Cardiac Disorders	2 percentage of participants Interval 1.3 to 3.0	3 percentage of participants Interval 2.4 to 3.7	6.6 percentage of participants Interval 6.1 to 7.3

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Atrial Fibrillation	2.8 percentage of participants Interval 2.0 to 3.9	4.3 percentage of participants Interval 3.6 to 5.1	6.5 percentage of participants Interval 6.0 to 7.2

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Biliary Events	1.8 percentage of participants Interval 1.2 to 2.8	2 percentage of participants Interval 1.6 to 2.6	4 percentage of participants Interval 3.5 to 4.5

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Hypertriglyceridemia	9.7 percentage of participants Interval 8.1 to 11.6	10.6 percentage of participants Interval 9.5 to 11.8	6 percentage of participants Interval 5.4 to 6.5

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Clinical Fractures	4.4 percentage of participants Interval 3.4 to 5.8	8.2 percentage of participants Interval 7.3 to 9.3	12.8 percentage of participants Interval 12.0 to 13.6

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Renal Failure	0.8 percentage of participants Interval 0.4 to 1.5	2.3 percentage of participants Interval 1.8 to 3.0	4.8 percentage of participants Interval 4.3 to 5.3

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of All Malignancies	3.2 percentage of participants Interval 2.3 to 4.3	4.4 percentage of participants Interval 3.7 to 5.2	6.6 percentage of participants Interval 6.0 to 7.2

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Different Types of Malignancies Malignancies- Gastrointestinal	1.1 percentage of participants Interval 0.6 to 1.9	1.1 percentage of participants Interval 0.8 to 1.6	1.5 percentage of participants Interval 1.2 to 1.8
Cumulative Incidence of Different Types of Malignancies Malignancies - Thyroid	—	0.1 percentage of participants Interval 0.0 to 0.3	0.2 percentage of participants Interval 0.1 to 0.3
Cumulative Incidence of Different Types of Malignancies Malignancies - Breast	0.4 percentage of participants Interval 0.1 to 0.9	0.6 percentage of participants Interval 0.4 to 1.0	1.4 percentage of participants Interval 1.1 to 1.7
Cumulative Incidence of Different Types of Malignancies Malignancies - Renal	—	0.1 percentage of participants Interval 0.0 to 0.3	0.1 percentage of participants Interval 0.0 to 0.2
Cumulative Incidence of Different Types of Malignancies Malignancies - Genital / Urogenital	0.5 percentage of participants Interval 0.2 to 1.2	0.4 percentage of participants Interval 0.2 to 0.7	0.5 percentage of participants Interval 0.3 to 0.7
Cumulative Incidence of Different Types of Malignancies Malignancies - Lung	0.3 percentage of participants Interval 0.1 to 0.8	0.4 percentage of participants Interval 0.2 to 0.7	0.3 percentage of participants Interval 0.2 to 0.5
Cumulative Incidence of Different Types of Malignancies Malignancies- Respiratory	0.1 percentage of participants Interval 0.0 to 0.5	—	0.1 percentage of participants Interval 0.0 to 0.2

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Depression	10.1 percentage of participants Interval 8.4 to 12.0	9.2 percentage of participants Interval 8.2 to 10.4	8.6 percentage of participants Interval 7.9 to 9.3

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Selected Ocular Events	8 percentage of participants Interval 6.6 to 9.8	12.5 percentage of participants Interval 11.3 to 13.8	10.8 percentage of participants Interval 10.1 to 11.6

SECONDARY outcome

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

Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.

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.

Outcome measures

Measure	Bazedoxifene n=1111 Participants Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Raloxifene n=2720 Participants Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.	Bisphosphonate n=6666 Participants Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.
Cumulative Incidence of Thyroid Disorders- Goitre	1.6 percentage of participants Interval 1.0 to 2.5	2.5 percentage of participants Interval 1.9 to 3.1	3.8 percentage of participants Interval 3.4 to 4.3

Adverse Events

Bazedoxifene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Raloxifene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bisphosphonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER