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

Primary Purpose

Osteoporosis in Postmenopausal Women

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Eldecalcitol
Native Vitamin D
Denosumab
Calcium
Sponsored by
Xi'an Honghui Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis in Postmenopausal Women

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Denosumab+Eldecalcitol

    Denosumab+Native Vitamin D+Calcium

    Arm Description

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

    Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA.
    the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA.
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
    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.
    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.
    1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.
    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 and month 12 in muscle strength by measuring grip strength.
    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).
    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).
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW).

    Full Information

    First Posted
    May 7, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Xi'an Honghui Hospital
    Collaborators
    Chugai Pharma China Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05884372
    Brief Title
    Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
    Official Title
    Comparison of Efficacy of Denosumab With Eldecalcitol or Native Vitamin D in Postmenopausal Women With Osteoporosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xi'an Honghui Hospital
    Collaborators
    Chugai Pharma China Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis in Postmenopausal Women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Denosumab+Eldecalcitol
    Arm Type
    Experimental
    Arm Description
    Denosumab (subcutaneous injection 60mg/6 months) combined with ELD (oral 0.75μg/day) for 12 months.
    Arm Title
    Denosumab+Native Vitamin D+Calcium
    Arm Type
    Active Comparator
    Arm Description
    Denosumab (subcutaneous injection 60mg/6 months) combined with native vitamin D (oral 800IU/day) and Calcium (oral 600mg/day) for 12 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Eldecalcitol
    Intervention Description
    the same as arm descriptions.
    Intervention Type
    Drug
    Intervention Name(s)
    Native Vitamin D
    Intervention Description
    the same as arm descriptions.
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab
    Intervention Description
    the same as arm descriptions.
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium
    Intervention Description
    the same as arm descriptions.
    Primary Outcome Measure Information:
    Title
    the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
    Description
    the percent change from baseline at month 12 in BMD at the lumbar spine L1-4.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
    Description
    the percent change from baseline at month 6 in BMD at the lumbar spine L1-4.
    Time Frame
    6 months
    Title
    the percent change from baseline at each visit in BMD at the femoral neck and total hip.
    Description
    the percent change from baseline at each visit in BMD at the femoral neck and total hip.
    Time Frame
    12 months
    Title
    the percent change from baseline at each visit in serum CTX,P1NP,PTH.
    Description
    the percent change from baseline at each visit in serum CTX,P1NP,PTH.
    Time Frame
    12 months
    Title
    the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA.
    Description
    the percent change from baseline at month 6 and month 12 in limb skeletal muscle content by DXA.
    Time Frame
    12 months
    Title
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
    Description
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring One Leg Standing (OLS).
    Time Frame
    12 months
    Title
    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).
    Description
    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.
    Time Frame
    12 months
    Title
    Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
    Description
    Incidence rate of new vertebral fracture and new non-vertebral fracture in 1 year.
    Time Frame
    12 months
    Title
    1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.
    Description
    1.the percent change from baseline at month 6 and month 12 in physical function by measuring 5 times chair stand.
    Time Frame
    12 months
    Title
    the percent change from baseline at month 6 and month 12 in muscle strength by measuring grip strength.
    Description
    the percent change from baseline at month 6 and month 12 in muscle strength by measuring grip strength.
    Time Frame
    12 months
    Title
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG).
    Description
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring Timed Up and Go (TUG).
    Time Frame
    12 months
    Title
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW).
    Description
    the percent change from baseline at month 6 and month 12 in body balance ability by measuring 10 Meter Walk (10MW).
    Time Frame
    12 months

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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