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

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ClinicalTrials.gov Identifier: NCT01470326
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01470326


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov 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:
Osteoporosis
Post menopausal women
SERM
Japanese
Viviant
Regulatory Post Marketing Commitment Plan
Long term treatment

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