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

NCT05884372 | Completed Phase 4

• 1 other identifier: ELD-IIS00X
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis in Postmenopausal Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Other Outcomes (6)

• 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.

  12 months

• the change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.

  12 months

Study Arms (2)

Denosumab+Eldecalcitol

EXPERIMENTAL

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

Drug: Eldecalcitol; Drug: Denosumab

Denosumab+Native Vitamin D+Calcium

ACTIVE COMPARATOR

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; Drug: Denosumab; Drug: Calcium

Interventions

Eldecalcitol DRUG

the same as arm descriptions.

Denosumab+Eldecalcitol

Native Vitamin D DRUG

the same as arm descriptions.

Denosumab+Native Vitamin D+Calcium

Denosumab DRUG

the same as arm descriptions.

Denosumab+Eldecalcitol; Denosumab+Native Vitamin D+Calcium

Calcium DRUG

the same as arm descriptions.

Denosumab+Native Vitamin D+Calcium

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Voluntarily participate in this study and sign the informed consent.

You may not qualify if:

• 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.
• 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..
• Patients who at screening have urinary tract stones detected on B-mode ultrasonography or who have a prior history of urolithiasis.
• 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).
• Patients with a history of malignant tumors.
• Patients judged by investigators to be unsuitable as subjects.

Sponsors & Collaborators

• Xi'an Honghui Hospital: lead
• Chugai Pharma China Co., Ltd.: collaborator

Study Sites (1)

Zeng,Yuhong

Xi'an, China

Location

MeSH Terms

Interventions

eldecalcitol; Denosumab; Calcium

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 1, 2023
• Study Start: August 24, 2023
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)