Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01793142

Enrollment

3430

Registered

2013-02-15

Start date

2013-10-24

Completion date

2017-05-31

Last updated

2018-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, postmenopausal, SERM

Brief summary

This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs

Detailed description

continuous enrollment

Interventions

DRUGViviant

Viviant (Bazedoxifene) 20mg once daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* Postmenopausal osteoporosis and osteopenia patients

Exclusion criteria

* Patients with active or past history of venous thromboembolic events including deep vein thrombosis, * Patients with pulmonary embolism and retinal vein thrombosis

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs	Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as unlikely or no, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.

Secondary

Measure	Time frame	Description
Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)	Baseline up to 3 months	DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Number of Participants With Abnormal X-ray Result	Baseline up to 3 months	Criteria for abnormality was based on investigator's discretion.
Overall Efficacy Evaluation of Viviant 20 mg Tablet	Baseline up to 3 months	Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
Number of Participants With Abnormal Biochemical Markers of Bone Turnover	Baseline up to 3 months	In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
Number of Participants With Abnormal Bone Mineral Density Result	Baseline up to 3 months	A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Number of Participants With Osteoporosis Related Fractures	Baseline up to 3 months	—

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Viviant Tablet 20 mg Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling.	3,423
Total	3,423

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Randomized not treated	7

Baseline characteristics

Characteristic	Viviant Tablet 20 mg	—
Age, Continuous Mean Age	69.51 years STANDARD_DEVIATION 10.03	—
Height Continuous	153.56 centimeter STANDARD_DEVIATION 5.87	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	3423 Participants	—
Sex: Female, Male Male	0 Participants	—
Weight Continuous	55.12 kilograms STANDARD_DEVIATION 8.26	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 3,423
other Total, other adverse events	192 / 3,423
serious Total, serious adverse events	17 / 3,423

Outcome results

Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

Time frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Population: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Viviant Tablet 20 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	209 Participants
Viviant Tablet 20 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	17 Participants

Primary

Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs

An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as unlikely or no, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.

Time frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)

Population: Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Viviant Tablet 20 mg	Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs	ADRs	132 Participants
Viviant Tablet 20 mg	Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs	Serious ADRs	3 Participants
Viviant Tablet 20 mg	Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs	Unexpected ADRs	93 Participants

Secondary

Number of Participants With Abnormal Biochemical Markers of Bone Turnover

In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.