An observational study in Osteoporosis, Postmenopausal, sponsored by Bayer. Completed at 1 site in Japan. Open to female participants. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by Bayer · Observational
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 148 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.
Exclusion Criteria:
Drug (incl. Placebo)
Drug: E2 transdermal (Julina, BAY86-5435)
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
Incidence of adverse drug reactions and serious adverse events in subject who received Julina
Time frame: After Julina administration, upto 3 years
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
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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