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Completed

NCT Number: NCT01470326

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bazedoxifene

Drug

For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Primary outcomes

  1. Number of Participants With Treatment-Related Adverse Events

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.

  2. Number of Participants With Any Fracture

    Time frame: 3 years

    Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.

Secondary outcomes

  1. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician.

  2. Number of Participants With Treatment-Related Adverse Events by Age

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

  3. Number of Participants With Treatment-Related Adverse Events by Smoking Status

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

  4. Number of Participants With Treatment-Related Adverse Events by Use of Steroid

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.

  5. Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.

  6. Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication

    Time frame: 3 years

    A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: VIOLINE

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2011
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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