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| Name | Class |
|---|---|
| JW Pharmaceutical | INDUSTRY |
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This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.
The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental | Pitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 2 mg or 4 mg once daily * The dosage is determined based on cholesterol levels and the physician's decision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months | nmol BCE/L | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood C-Telopeptide of Type I Collagen levels | ng/L | 6 and 12 months |
| Change in blood Osteocalcin levels | ng/mL | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the outcomes after 12 months | bone mineral density and bone metabolism markers | 24 months, up to 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo Soo, M.D. Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D006937 | Hypercholesterolemia |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
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| Change in urinary N-Telopeptide of Type I Collagen levels | nmol BCE/L | 6 and 12 months |
| Change in blood Procollagen Type 1 N-Terminal Propeptide levels | ng/mL | 6 and 12 months |
| Change in blood LDL-cholesterol levels | mg/dL | 6 and 12 months |
| Change in blood HbA1c levels | 6 and 12 months |
| Changes in bone mineral density | measured by dual-energy X-ray absorptiometry | 12 months |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |