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

Pfizer

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Bazedoxifene

Study type: Observational

Funder types: Industry

Identifiers

NCT01470326

B1781007

Details and patient eligibility

About

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.

Full 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 patients enrolled into the investigation at random.

Enrollment: 3,187 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

3,187 participants in 1 patient group

Bazedoxifene Tablets

Description:

Subjects taking Bazedoxifene Tablets

Treatment:

Drug: Bazedoxifene