Trial Condition(s):

Osteoporosis, Postmenopausal

Julina post-marketing surveillance for postmenopausal osteoporosis in Japan

Bayer Identifier:

15075

ClinicalTrials.gov Identifier:

NCT01397955

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
-  Patients who received Julina for postmenopausal osteoporosis
Exclusion Criteria
-  Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
148
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Julina (Estradiol, BAY86-5435)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design