Efficacy and Safety of Combination Denosumab With Eldecalcitol for Postmenopausal Women With Osteoporosis.(ESCORT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-24

Study Completion Date

2025-07-16

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.

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Detailed Description

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Conditions

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Osteoporosis in Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denosumab+Eldecalcitol

Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.

Group Type EXPERIMENTAL

Eldecalcitol

Intervention Type DRUG

the same as arm descriptions.

Denosumab

Intervention Type DRUG

the same as arm descriptions.

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.

Group Type ACTIVE_COMPARATOR

Native Vitamin D

Intervention Type DRUG

the same as arm descriptions.

Denosumab

Intervention Type DRUG

the same as arm descriptions.

Calcium

Intervention Type DRUG

the same as arm descriptions.

Interventions

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Eldecalcitol

the same as arm descriptions.

Intervention Type DRUG

Native Vitamin D

the same as arm descriptions.

Intervention Type DRUG

Denosumab

the same as arm descriptions.

Intervention Type DRUG

Calcium

the same as arm descriptions.

Intervention Type DRUG

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, 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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No