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

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Viviant

• Registration Number: NCT01793142
• Lead Sponsor: 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

Detailed Description

continuous enrollment

Study Timeline

• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Study Start: 2013-10-24
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2018-05
• Results First Submitted: 2018-05-31
• Results First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Results First Posted: 2018-12-24
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Viviant treatment group	Viviant	Viviant treatment group

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.
Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs	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

Name	Time	Method
Overall Efficacy Evaluation of Viviant 20 mg Tablet	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.
Number of Participants With Osteoporosis Related Fractures	Baseline up to 3 months
Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)	Baseline up to 3 months	DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Number of Participants With Abnormal X-ray Result	Baseline up to 3 months	Criteria for abnormality was based on investigator's discretion.
Number of Participants With Abnormal Bone Mineral Density Result	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.
Number of Participants With Abnormal Biochemical Markers of Bone Turnover	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.

Trial Locations

Locations (60)

Inje University Haeundae Paik Hospital; 🇰🇷 Haeundae-gu, Busan, Korea, Republic of

The Catholic University of Korea, Seoul St.Mary's Hospital; 🇰🇷 Seoul, Capital Metropolitan, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan-si, Chuncheongnam-do, Korea, Republic of

Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital; 🇰🇷 Wonju-Si, Gangwon-do, Korea, Republic of

Dongguk University Gyeongju Hospital; 🇰🇷 Gyeongju-si, Gyeongbuk, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang-si, Gyeonggi-do, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon-Si, Gyeonggi-do, Korea, Republic of

Sejong Hospital; 🇰🇷 Bucheon-Si, Gyeonggi-do, Korea, Republic of

Dongguk University Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

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