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The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis
The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risendronate and Cholecalciferol combination | Experimental | risedronate 150mg and cholecalciferol 30,000 IU 1 tablet + Placebo(for risedronate 150mg) 1 tablet by once a month. |
|
| Risedronate | Active Comparator | risedronate 150mg 1 tablet + Placebo(for risedronate 150mg and cholecalciferol 30,000 IU) 1 tablet by once a month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate combine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks. | 16 weeks form first drug adminstration. |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers. | Secondary end point is :
| 16 weeks form first drug administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyoung-Moo Park, MD | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang university hospital | Seoul | 156-755 | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Risedronate | Drug |
|
|
| Placebo(for Risedronate) | Drug |
|
|
| Placebo(for risedronate combine) | Drug |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |