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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793142
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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

Condition or disease Intervention/treatment
Osteoporosis Drug: Viviant

Detailed Description:
continuous enrollment

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Study Type : Observational
Actual Enrollment : 3430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
Actual Study Start Date : October 24, 2013
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
Viviant treatment group
Viviant treatment group
Drug: Viviant
Viviant (Bazedoxifene) 20mg once daily




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Postmenopausal osteoporosis and osteopenia patients
Criteria

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

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): NCT01793142


Locations
Show Show 60 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01793142    
Other Study ID Numbers: B1781047
First Posted: February 15, 2013    Key Record Dates
Results First Posted: December 24, 2018
Last Update Posted: December 24, 2018
Last Verified: May 2018
Keywords provided by Pfizer:
Osteoporosis
postmenopausal
SERM
Additional relevant MeSH terms:
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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