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The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) in Korean postmenopausal osteoporotic women(Phase IV)
The purpose of this study is to evaluate the Efficacy and the Safety of Monthly(RisenexM group) versus Weekly Oral risedronate(Risenexsplus group) with Vitamin D in compliance, improvement of vitaminD and BMD in Korean postmenopausal osteoporotic women(Phase IV)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risenex M | Experimental | Patients who were treated with Resenex M (Risendronate/Cholecalciferol combination in one tablet) once a month for 12months |
|
| Risenex Plus | Active Comparator | Patients who were treated with Risenex plus (Risendronate/Cholecalciferol combination in one tablet) once a week for 12months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate/Cholecalciferol combination(montly) | Drug | once a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| The propotion of patients with 25(Oh)D level <20mg/ml of 12 months | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Bone Mineral Density(BMD) value | The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups) | 1year |
| The change of PTH(Parathyroid hormone value) |
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Inclusion Criteria:
Female osteoporosis patients over 19years of age(with menopause).
Definition of osteporosis
Definition of menopause(can be one of three condition)
Patients who can be treated with oral bisphosphonate drugs
Patients who have adequate to be measured DXA(Dual energy x-ray absorptiometry)
Patients who made a voluntary agreement after explanation of this study
Patients who participated in clinical trial(HL_RSNP_401) must have taken the Risenexplus and finish the study for 12 months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Youngki Min, MD | Samsung Medical Center Seoul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| Risedronate/Cholecalciferol combination(weekly) | Drug | once a week |
|
|
The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups) |
| 6months,1 year |
| The change of Compliance - overall groups of Risenex plus vs Risenex M | The change of Bone Mineral Density(BMD) value[Time frame: 1 year] The change of PTH(Parathyroid hormone value) [Time frame:6months,1 year] The change of Compliance - overall groups of Risenex plus vs Risenex M(2groups | 1year |
| The change of 25(Oh)D level in patients. | 6months,1year |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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