Trial Condition(s):
Osteoporosis, Postmenopausal
Wellnara post-marketing surveillance in Japan (WELLNARA)
Bayer Identifier:
15041
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Patients who received Wellnara for postmenopausal osteoporosis
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug use investigation of Wellnara Tablet
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subject who received WellnaraTimeframe: After Wellnara administration, up to 3 years
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of WellnaraTimeframe: At baseline and after Wellnara administration, up to 3 years
- Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worseTimeframe: At baseline and after Wellnara treatment, up to 3 years
Additional Information
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