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In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.
Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Alfacaocidol | Experimental | Ahead of Eldecalcitol treatment, this group has not taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient. |
|
| Alfacalcidol | Experimental | Ahead of Eldecalcitol treatment, this group has taken Alfacaocidol before. Eldecalcitol: the commercial name is Edirol We prescribe Edirol 0.5 or 0.75ug per day into each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edirol | Drug | Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with bone turnover markers as a Measure of bone quality | Bone formation and bone absorption markers will be evaluated at each time point | At 4 months after the initial treatment |
| Number of Participants with bone turnover markers as a Measure of bone quality | Bone formation and bone absorption markers will be evaluated at each time point | At 1 year after the initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with bone mineral density as a Measure of bone quality | Bone mineral density will be evaluated at each time point | At 4 months after the initial treatment |
| Number of Participants with bone mineral density as a Measure of bone quality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yukio Nakamura, MD, PhD | Contact | +81-263-37-2659 | yxn14@aol.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yukio Nakamura, MD, PhD | Shinshu University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yukio Nakamura | Recruiting | Matsumoto | Nagano | 3908621 | 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 |
|---|---|
| C547512 | eldecalcitol |
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Bone mineral density will be evaluated at each time point |
| At 1 year after the initial treatment |
| D009750 |
| Nutritional and Metabolic Diseases |