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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 9, 2011
Last updated: September 10, 2014
Last verified: September 2014

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
Drug: Bazedoxifene

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Viviant Osteoporosis Long Term Treatment In Post Menopausal Women (VIOLINE)

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 ] [ Designated as safety issue: Yes ]
  • Occurrence of all fracture. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment related unlisted adverse events in Japanese Package Insert. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Risk factors likely to affect the frequency of treatment related adverse events. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3300
Study Start Date: November 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 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:   40 Years and older
Genders 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:
No publications provided

Responsible Party: Pfizer Identifier: NCT01470326     History of Changes
Other Study ID Numbers: B1781007
Study First Received: November 9, 2011
Last Updated: September 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Bone Density Conservation Agents
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators processed this record on November 23, 2014