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

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 Overview

• Status: Completed
• Conditions: Osteoporosis in Postmenopausal Women
• Intervention / Treatment: Drug: Eldecalcitol; Drug: Denosumab; Drug: Native Vitamin D; Drug: Calcium

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Xi'an, China
    • Zeng,Yuhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Denosumab; the same as arm descriptions.; Drug: Native Vitamin D; the same as arm descriptions.; Drug: Calcium; the same as arm descriptions.

What is the study measuring?

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 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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xi'an Honghui Hospital
• Collaborators: Chugai Pharma China Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): July 16, 2025
• Study Completion (Actual): July 16, 2025

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Elements; Metals; Blood Coagulation Factors; Metals, Alkaline Earth; Denosumab; Calcium; eldecalcitol
• Other Study ID Numbers: ELD-IIS00X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No