Osteoporosis, Postmenopausal
Conditions
Keywords
Wellnara, 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 Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.
Interventions
Patients in daily life treatment receiving Wellnara 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 Wellnara 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 Wellnara | After Wellnara administration, up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara | At baseline and after Wellnara administration, up to 3 years |
| Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse | At baseline and after Wellnara treatment, up to 3 years |
Countries
Japan
Outcome results
None listed