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

Pfizer

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Viviant

Study type: Observational

Funder types: Industry

Identifiers

NCT01793142

B1781047

Details and patient eligibility

About

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

Full description

continuous enrollment

Enrollment: 3,430 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

3,430 participants in 1 patient group

Viviant treatment group

Description:

Viviant treatment group

Treatment:

Drug: Viviant