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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Osteoporosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Bazedoxifene Tablets

Subjects taking Bazedoxifene Tablets

Bazedoxifene

Intervention Type DRUG

For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Interventions

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Bazedoxifene

For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Intervention Type DRUG

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No