Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SERM plus ELD | Active Comparator | To examine the effects of SERM plus ELD in osteoporosis patients |
|
| BP plus ELD | Active Comparator | To examine the effects of BP plus ELD in osteoporosis patients |
|
| ELD alone | Active Comparator | To examine the effects of ELD alone in osteoporosis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" | Drug | To examine the effects of SERM and ELD in osteoporosis patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone | Change from Baseline Values of bone mineral density at 2 years in each group |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yukio Nakamura | Contact | +81263372576 | yxn14@aol.jp |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yukio Nakamura | Recruiting | Matsumoto | Nagano | 3908621 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bisphosphonates and ELD "Edirol®Tablet 0.75ug" | Drug | To examine the effects of BP and ELD in osteoporosis patients |
|
| ELD "Edirol®Tablet 0.75ug" | Drug | To examine the effects of ELD in osteoporosis patients |
|
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided