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Completed

NCT Number: NCT01793142

Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs

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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

Primary location

Inje University Haeundae Paik Hospital, Haeundae-gu, Busan, South Korea

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About this study

continuous enrollment

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal osteoporosis and osteopenia patients

Exclusion criteria

  • Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
  • Patients with pulmonary embolism and retinal vein thrombosis

Treatment and study plan

Viviant

Drug

Viviant (Bazedoxifene) 20mg once daily

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

  2. Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs

    Time frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)

    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.

Secondary outcomes

  1. Overall Efficacy Evaluation of Viviant 20 mg Tablet

    Time frame: Baseline up to 3 months

    Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.

  2. Number of Participants With Osteoporosis Related Fractures

    Time frame: Baseline up to 3 months

  3. Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)

    Time frame: Baseline up to 3 months

    DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.

  4. Number of Participants With Abnormal X-ray Result

    Time frame: Baseline up to 3 months

    Criteria for abnormality was based on investigator's discretion.

  5. Number of Participants With Abnormal Bone Mineral Density Result

    Time frame: Baseline up to 3 months

    A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.

  6. Number of Participants With Abnormal Biochemical Markers of Bone Turnover

    Time frame: Baseline up to 3 months

    In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2013
Registry last updated
Dec 24, 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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