Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis
NCT ID: NCT05902078
Last Updated: 2024-05-16
Study Results
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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RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2023-09-27
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eldecalcitol
Participants receive oral eldecalcitol 0.75μg daily for 12 months
Eldecalcitol capsules
Oral eldecalcitol 0.75μg daily
Calcitriol
Participants receive oral calcitriol 0.5μg daily for 12 months
Calcitriol capsules
Oral calcitriol 0.5μg daily
Interventions
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Eldecalcitol capsules
Oral eldecalcitol 0.75μg daily
Calcitriol capsules
Oral calcitriol 0.5μg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. BMD (determined by DXA) of lumbar L1-4 or total hip or femoral neck met one of the following conditions at screening:
1\) low BMD: -2.5\<T\< -1.0, without vertebral and fragility fracture history 2) mild osteoporosis: T≤-2.5, without vertebral and fragility fracture history 3. Ambulatory outpatients 4. Written informed consent
Exclusion Criteria
2. Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, rheumatoid arthritis, poorly controlled diabetes mellitus (HbA1c\>9%), or other conditions that can cause secondary osteoporosis, or treatment with glucocorticoids in the 2 months prior to study entry
3. Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate oral for 6 months or more in the 3 years prior to study entry; or had received parathyroid hormone once or more in the 3 years before entering the study; or received 2 weeks or more of calcitonin or vitamin K or active vitamin D or selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for bone pine within 2 months prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
4. Urolithiasis at screening
5. Hypercalcemia (serum calcium \>10.4 mg/dL), or hypercalciuria (urine calcium\>400 mg/gCr), or hyperuricemia (above 420 μmol/L in men and 360 μmol/L in women)
6. Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
7. Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
8. History of allergy to vitamin D
9. Any condition which in the opinion of the investigator unfit for the study
50 Years
FEMALE
No
Sponsors
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Chugai Pharma China Co., Ltd.
UNKNOWN
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Responsible Party
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Zhenlin Zhang, MD
Chief Physician
Principal Investigators
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Zhenlin Zhang
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Locations
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The Second Xiangya Hospital of Central South University
Changsha, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin, , China
Huai 'an First People's Hospital
Huai'an, , China
Liaocheng People's Hospital
Liaocheng, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
Jiangsu Geriatric Hospital
Nanjin, , China
The First Hospital of Ningbo
Ningbo, , China
The Sixth Hospital of Ningbo
Ningbo, , China
Pingxiang People's Hospital
Pingxiang, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Shanghai Pudong New Area Punan Hospital
Shanghai, , China
Shanghai Sixth People's Hospital
Shanghai, , China
Zhongshan Hosiptal Affiliated to Fudan University
Shanghai, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
The First Hospital of Shanxi Medical University
Taiyuan, , China
The Second Hospital of Shanxi Medical University
Taiyuan, , China
Tianjin Hospital
Tianjin, , China
Xi'an Honghui Hospital
Xi'an, , China
Xuzhou Central Hospital
Xuzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Zhifeng Cheng
Role: primary
Other Identifiers
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2023MDEDR0007
Identifier Type: -
Identifier Source: org_study_id
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