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This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eldecalcitol soft capsules | Drug | 0.75 μg orally once a day during the intensive monitoring period. (The dose can be appropriately reduced to 0.5 μg according to symptoms, once a day.) |
| Measure | Description | Time Frame |
|---|---|---|
| the rates of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake | one year from Edirol dosing date | |
| the odds ratios of hypercalcemia and 95% confidence intervals for patients with and without calcium preparation intake | one year from Edirol dosing date | |
| the proportion of each type of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) | through study completion, up to one year | |
| the incidence of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) | through study completion, up to one year | |
| the severity of adverse drug reactions (including hypercalcemia, urolithiasis, etc.) | through study completion, up to one year |
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Inclusion Criteria:
Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
Exclusion Criteria:
Exclude if any of the following:
Started Edirol before ICF signature
Did not sign ICF
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Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ritsu Ki | Contact | only use E-mail | edrdimdisclosure@chugai-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Weibo Xia | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |