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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470326
First received: November 9, 2011
Last updated: May 6, 2013
Last verified: May 2013

November 9, 2011
May 6, 2013
November 2011
July 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01470326 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
Viviant Osteoporosis Long Term Treatment In Post Menopausal Women (VIOLINE)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.

Osteoporosis
Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
Bazedoxifene Tablets
Subjects taking Bazedoxifene Tablets
Intervention: Drug: Bazedoxifene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
3300
July 2016
July 2016   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01470326
B1781007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP