Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Denosumab+Eldecalcitol Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months. |
Drug: Eldecalcitol
the same as arm descriptions.
Drug: Denosumab
the same as arm descriptions.
|
| Active Comparator: Denosumab+Native Vitamin D+Calcium 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
the same as arm descriptions.
Drug: Denosumab
the same as arm descriptions.
Drug: Calcium
the same as arm descriptions.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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 limb skeletal muscle content by DXA.
- the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS). [12 months]
the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
- 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.
- 1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand. [12 months]
1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.
- 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 muscle strength by measuring grip strength.
- 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 Timed Up and Go (TUG).
- the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW). [12 months]
the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Xi'an Honghui Hospital
- Chugai Pharma China Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ELD-IIS00X