Osteoporosis, Postmenopausal
Conditions
Keywords
Julina, 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.
Interventions
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Patients who received Julina for postmenopausal osteoporosis
Exclusion criteria
* Patients who are contraindicated based on the product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions and serious adverse events in subject who received Julina | After Julina administration, upto 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina | At baseline and after Julina administration, upto 1 year |
| Change from baseline in grad of hot flush and sweating at the end of Julina treatment | At baseline and at end of Julina treatment, upto 1 year |
| Change from baseline in with/without vaginal atrophy at the end of Julina treatment | At baseline and at end of Julina treatment, upto 1 year |
Countries
Japan
Outcome results
None listed