Osteoporosis in Postmenopausal Women
Conditions
Brief summary
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.
Interventions
DRUGEldecalcitol
the same as arm descriptions.
DRUGNative Vitamin D
the same as arm descriptions.
DRUGDenosumab
the same as arm descriptions.
DRUGCalcium
the same as arm descriptions.
Sponsors
Chugai Pharma China Co., Ltd.
Xi'an Honghui Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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, or with low mineral density (-2.5 \< T-score \< -1.0) plus a fragility fracture of the proximal humerus or distal forearm, or a history of vertebral compression fracture. * 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 \[HbA1c\>9.0%\]), 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, or received treatment with glucocorticoids, vitamin K, active vitamin D compounds, selective estrogen receptor modulators, calcitonin, hormone replacement therapy, or teriparatide within the 8 weeks prior to study enrollment.. * 3.Patients who at screening have urinary tract stones detected on B-mode ultrasonography or who have a prior history of urolithiasis. * 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 a history of malignant tumors. * 6.Patients judged by investigators to be unsuitable as subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percent change from baseline at month 12 in BMD at the lumbar spine L1-4. | 12 months | the percent change from baseline at month 12 in BMD at the lumbar spine L1-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the percent change from baseline at month 6 in BMD at the lumbar spine L1-4. | 6 months | the percent change from baseline at month 6 in BMD at the lumbar spine L1-4. |
| 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 BMD at the femoral neck and total hip. |
| the percent change from baseline at each visit in serum CTX,P1NP,PTH. | 12 months | the percent change from baseline at each visit in serum CTX,P1NP,PTH. |
| 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). | 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 scale ranges from 16 to 80, with higher scores meaning higher risk. |
| Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year. | 12 months | Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG). | 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 One Leg Standing (OLS). | 12 months | 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 limb skeletal muscle content by DXA. | 12 months | the change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA. |
| 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 physical function by measuring 5 times chair stand. |
| the change from baseline at month 6 and month 12 in muscle strength by measuring handgrip strength. | 12 months | the change from baseline at month 6 and month 12 in muscle strength by measuring grip strength. |
| 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 10 Meter Walk (10MW). |
Countries
China
Outcome results
None listed