Drug Use Investigation of Wellnara Tablet

Wellnara Post-marketing Surveillance in Japan

Sponsors

Lead sponsor: Bayer

Source Bayer
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.

Overall Status Completed
Start Date March 2009
Completion Date September 2014
Primary Completion Date August 2014
Study Type Observational
Primary Outcome
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 Outcome
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
Enrollment 411
Condition
Intervention

Intervention type: Drug

Intervention name: E2/LNG oral (Wellnara, BAY86-5029)

Description: Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis

Arm group label: Group 1

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Patients who received Wellnara for postmenopausal osteoporosis

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
facility
Location Countries

Japan

Verification Date

September 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Group 1

Description: Drug (incl. Placebo)

Acronym WELLNARA
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov