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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470326
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : October 19, 2016
Information provided by (Responsible Party):

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 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.

Condition or disease Intervention/treatment
Osteoporosis Drug: Bazedoxifene

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 patients enrolled into the investigation at random.

Study Type : Observational
Actual Enrollment : 3185 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Study Start Date : November 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Primary Outcome Measures :
  1. The frequency of treatment related adverse events. [ Time Frame: 3 years ]
  2. Occurrence of all fracture. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 3 years ]
  2. Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01470326

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01470326     History of Changes
Other Study ID Numbers: B1781007
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Pfizer:
Post menopausal women
Regulatory Post Marketing Commitment Plan
Long term treatment

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents