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| Name | Class |
|---|---|
| Chugai Pharma China Co., Ltd. | UNKNOWN |
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Primary objective:
To compare the bone mineral density (BMD) change under the treatment of denosumab with eldecalcitol or native vitamin D in postmenopausal women with osteoporosis on bone mineral density.
Secondary objective:
To compare the efficacy of denosumab with eldecalcitol or native vitamin D treatment in postmenopausal women with osteoporosis on bone turnover markers, serum PTH, serum calcium, serum phosphorus, muscle mass, muscle strength, body balance ability, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab+Eldecalcitol | Experimental | Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months. |
|
| Denosumab+Native Vitamin D+Calcium | Active Comparator | Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eldecalcitol | Drug | the same as arm descriptions. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the percent change from baseline at month 12 in BMD at the lumbar spine L1-4. | the percent change from baseline at month 12 in BMD at the lumbar spine L1-4. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the percent change from baseline at month 6 in BMD at the lumbar spine L1-4. | the percent change from baseline at month 6 in BMD at the lumbar spine L1-4. | 6 months |
| the percent change from baseline at each visit in BMD at the femoral neck and total hip. |
| Measure | Description | Time Frame |
|---|---|---|
| the change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS). | the change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS). | 12 months |
| the change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeng,Yuhong | Xi'an | China |
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| ID | Term |
|---|---|
| C547512 | eldecalcitol |
| D000069448 | Denosumab |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Native Vitamin D |
| Drug |
the same as arm descriptions. |
|
| Denosumab | Drug | the same as arm descriptions. |
|
| Calcium | Drug | the same as arm descriptions. |
|
the percent change from baseline at each visit in BMD at the femoral neck and total hip. |
| 12 months |
| the percent change from baseline at each visit in serum CTX,P1NP,PTH. | the percent change from baseline at each visit in serum CTX,P1NP,PTH. | 12 months |
| the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16). | the score change from baseline at month 6 and month 12 in quality of life by 16-item Assessment of Health-Related Quality of Life in Osteoporosis,(ECOS-16). The scale ranges from 16 to 80, with higher scores meaning higher risk. | 12 months |
| Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year. | Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year. | 12 months |
the change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA. |
| 12 months |
| the change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand. | the change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand. | 12 months |
| the change from baseline at month 6 and month 12 in muscle strength by measuring handgrip strength. | the change from baseline at month 6 and month 12 in muscle strength by measuring grip strength. | 12 months |
| the change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW). | the change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW). | 12 months |
| the change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG). | the change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG). | 12 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |