Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

Sponsors

Lead sponsor: Bayer

Source Bayer
Brief Summary

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.

Overall Status Completed
Start Date January 2009
Completion Date April 2014
Primary Completion Date January 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Incidence of adverse drug reactions and serious adverse events in subject who received Julina After Julina administration, upto 3 years
Secondary Outcome
Measure Time Frame
Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina At baseline and after Julina administration, upto 3 years
Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse At baseline and at end of Julina treatment, upto 3 years
Enrollment 148
Condition
Intervention

Intervention type: Drug

Intervention name: E2 transdermal (Julina, BAY86-5435)

Description: Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

Arm group label: Group 1

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
facility
Location Countries

Japan

Verification Date

April 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Group 1

Description: Drug (incl. Placebo)

Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov