Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Xi'an Honghui Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts 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.
Arms & Interventions
Denosumab+Eldecalcitol
Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
Intervention: Eldecalcitol (Drug)
Denosumab+Eldecalcitol
Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
Intervention: Denosumab (Drug)
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.
Intervention: Native Vitamin D (Drug)
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.
Intervention: Denosumab (Drug)
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.
Intervention: Calcium (Drug)
Outcomes
Primary Outcomes
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 12 in BMD at the lumbar spine L1-4.
Secondary Outcomes
- 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.(12 months)
- 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).(12 months)
- Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.(12 months)
Investigators
Yuhong Zeng
Chief Physician
Xi'an Honghui Hospital