Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Osteoporosis

Eligibility:

FEMALE

Brief Summary

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 clinic...

Detailed Description

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 pati...

Eligibility Criteria

Inclusion

  • Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2016

Estimated Enrollment :

3187 Patients enrolled

Trial Details

Trial ID

NCT01470326

Start Date

November 1 2011

End Date

June 1 2016

Last Update

November 5 2018

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