Osteoporosis, Postmenopausal Clinical Trial
— JULINA-CLIMAOfficial title:
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
Verified date | April 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 506 |
Est. completion date | April 15, 2014 |
Est. primary completion date | April 15, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients who received Julina for postmenopausal osteoporosis Exclusion Criteria: - Patients who are contraindicated based on the product label |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse drug reactions and serious adverse events in subject who received Julina | After Julina administration, upto 1 year | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 |
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