Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.

Conditions
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Osteoporosis in Postmenopausal Women

Intervention / Treatment
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* Drug: Eldecalcitol
* Drug: Native Vitamin D
* Drug: Denosumab
* Drug: Calcium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Postmenopausal patients with osteoporosis, measured by dual energy X-ray absorptiometry (DXA), the T value of lumbar spine, femoral neck or total hip BMD is ≤-2.5. 2.Voluntarily participate in this study and sign the informed consent. Exclusion Criteria: 1.Suffering from hyperthyroidism, Cushing's syndrome, hypogonadism, poorly controlled diabetes mellitus (glycated hemoglobin [HbA1c>7.5%]), or other diseases that may lead to secondary osteoporosis. 2.Patients who have received denosumab therapy before screening: received oral bisphosphonate treatment more than 3 years or received bisphosphonate treatment within 6 months before screening, glucocorticoids, calcitonin, vitamin K, active vitamin D, gonadotropin-releasing hormone agonists, isotopes Flavonoids, selective estrogen receptor modulators, or hormone replacement therapy. 3.Patients with urolithiasis revealed by B-ultrasound at screening. 4.Corrected serum calcium value at screening exceeds 2.6mmol/L (10.4mg/dL) or serum calcium value is lower than 2.12mmol/L(8 mg/dL) or hypercalciuria (> 0.4 mg/dL GF), or chronic kidney disease (eGFR < 30 mL/min/1.73 m2). 5.Patients with malignant tumors or patients with a history of malignant tumors within the previous 3 years. 6.Patients judged by investigators to be unsuitable as subjects.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab+Eldecalcitol<br>Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months. | Drug: Eldecalcitol<br>* the same as arm descriptions.<br>Drug: Denosumab<br>* the same as arm descriptions.<br>|
| Active Comparator: Denosumab+Native Vitamin D+Calcium<br>Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months. | Drug: Native Vitamin D<br>* the same as arm descriptions.<br>Drug: Denosumab<br>* the same as arm descriptions.<br>Drug: Calcium<br>* the same as arm descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA. | the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA. | 12 months | 
| the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS). | the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS). | 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 | 
| 1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand. | 1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand. | 12 months | 
| the percent change from baseline at month 6 and month 12 in muscle strength by measuring grip strength. | the percent change from baseline at month 6 and month 12 in muscle strength by measuring grip strength. | 12 months | 
| the percent change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG). | the percent change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG). | 12 months | 
| the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW). | the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW). | 12 months |