Clinical Trial: Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
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.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Incidence of adverse drug reactions and serious adverse events in subject who received Julina [ Time Frame: After Julina administration, upto 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina [ Time Frame: At baseline and after Julina administration, upto 3 years ]
- Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse [ Time Frame: At baseline and at end of Julina treatment, upto 3 years ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: July 19, 2011
Date Started: January 2009
Date Completion:
Last Updated: April 16, 2015
Last Verified: April 2015
