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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 9, 2011
Last updated: October 18, 2016
Last verified: October 2016
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 Intervention
Osteoporosis Drug: Bazedoxifene

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

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

Enrollment: 3185
Study Start Date: November 2011
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01470326

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01470326     History of Changes
Other Study ID Numbers: B1781007
Study First Received: November 9, 2011
Last Updated: October 18, 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
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on August 17, 2017