Text Size

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
History of Changes
  Purpose

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 Phase
Osteoporosis
 Drug: Bazedoxifene
 Phase 4

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:

U.S. FDA Resources

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.

  Eligibility

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470326

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470326     History of Changes
Other Study ID Numbers: B1781007
Study First Received: November 9, 2011
Last Updated: May 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 22, 2013