Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

Study Overview
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Brief Summary
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In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.

Detailed Description
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All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Official Title
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Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Bazedoxifene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene. Exclusion Criteria: Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis Subject in long-term immovability (postoperative recovery, long-term bed rest) Subject with antiphospholipid antibody syndrome
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bazedoxifene Tablets<br>Subjects taking Bazedoxifene Tablets | Drug: Bazedoxifene<br>* For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician. | 3 years | 
| Number of Participants With Any Fracture | Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included fracture in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician. | 3 years | 
| Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years | 
| Number of Participants With Treatment-Related Adverse Events by Smoking Status | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years | 
| Number of Participants With Treatment-Related Adverse Events by Use of Steroid | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years | 
| Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | 3 years | 
| Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Post menopausal women, SERM, Japanese, Viviant, Regulatory Post Marketing Commitment Plan, Long term treatment