Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.

Phase 4

Recruiting

• Conditions: Osteoporosis in Postmenopausal Women
• Interventions: Drug: Eldecalcitol; Drug: Native Vitamin D; Drug: Denosumab; Drug: Calcium

• Registration Number: NCT05884372
• Lead Sponsor: Xi'an Honghui Hospital

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:
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Study Start: 2023-08-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab+Eldecalcitol	Eldecalcitol	Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
Denosumab+Eldecalcitol	Denosumab	Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
Denosumab+Native Vitamin D+Calcium	Native Vitamin D	Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.
Denosumab+Native Vitamin D+Calcium	Denosumab	Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.
Denosumab+Native Vitamin D+Calcium	Calcium	Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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).
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 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 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.
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).

Trial Locations

Locations (1)

Zeng,Yuhong; 🇨🇳 Xi'an, China