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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
the same as arm descriptions.
the same as arm descriptions.
the same as arm descriptions.
Zeng,Yuhong
Xi'an, China
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.
Time frame: 12 months
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.
Time frame: 6 months
the percent change from baseline at each visit in BMD at the femoral neck and total hip.
the percent change from baseline at each visit in BMD at the femoral neck and total hip.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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the same as arm descriptions.