Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

Bayer

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: E2 transdermal (Julina, BAY86-5435)

Study type: Observational

Funder types: Industry

Identifiers

NCT01397955

15075

Details and patient eligibility

About

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.

Enrollment: 148 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received Julina for postmenopausal osteoporosis

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

148 participants in 1 patient group

Group 1

Description:

Drug (incl. Placebo)

Treatment:

Drug: E2 transdermal (Julina, BAY86-5435)