Wellnara Post-marketing Surveillance in Japan
NCT01401114 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411
Last updated 2015-09-28
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.
Conditions
- Osteoporosis, Postmenopausal
Interventions
- DRUG
-
E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-09-30
Countries
- Japan
More Related Trials
-
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
NCT01128257 ·Status: COMPLETED
-
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
NCT00212667 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis
NCT01544894 ·Status: COMPLETED ·Phase: PHASE4
-
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
NCT00794443 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
NCT00504166 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
NCT02063854 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
NCT00431444 ·Status: COMPLETED ·Phase: PHASE4
-
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
NCT00680953 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
NCT03435094 ·Status: UNKNOWN
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
NCT01224717 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
NCT02948881 ·Status: COMPLETED ·Phase: PHASE4
-
Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
NCT00290212 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia
NCT05386784 ·Status: COMPLETED ·Phase: PHASE4
-
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
NCT02156960 ·Status: UNKNOWN ·Phase: PHASE4
-
Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
NCT05902078 ·Status: RECRUITING ·Phase: PHASE4
-
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
NCT02598934 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
NCT01575834 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
NCT02598440 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
NCT01753856 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
NCT05884372 ·Status: COMPLETED ·Phase: PHASE4
-
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
NCT01495000 ·Status: COMPLETED ·Phase: PHASE3
-
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
NCT06804590 ·Status: RECRUITING ·Phase: PHASE3
-
Comparative Efficacy, Safety, PK, and Immunogenicity Study
NCT05853354 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
NCT04757376 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.
NCT00545207 ·Status: COMPLETED ·Phase: PHASE3