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| ID | Type | Description | Link |
|---|---|---|---|
| ONO-5920-05 |
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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Monthly - Dose 1 | Experimental | Monthly intermittent administration, dose 1 |
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| 2. Monthly - Dose 2 | Experimental | Monthly intermittent administration, dose 2 |
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| 3. Daily | Active Comparator | Daily administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM529 / ONO-5920 | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method | At the final evaluation point |
| Measure | Description | Time Frame |
|---|---|---|
| Time-course changes in the percent change of bone metabolism markers | Through the treatment period | |
| Time-course changes in the total femoral bone mineral density by the DXA method | Through the treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiomi Minamide | Ono Pharmaceutical Co., Ltd. | Study Director |
| Central Contact | Clinical Development Administration Dept., Astellas Pharma Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido | Japan | |||||
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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 |
|---|---|
| C087958 | YM 529 |
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| Assessment of adverse events, lab test values | Through the treatment period |
| Frequency of fracture | At the final evaluation point |
| Kansai |
| Japan |
| Kantou | Japan |
| Kyusyu | Japan |
| Shikoku | Japan |
| D009750 |
| Nutritional and Metabolic Diseases |