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| Name | Class |
|---|---|
| Chugai Pharma China Co., Ltd. | UNKNOWN |
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To investigate the efficacy and safety of eldecalcitol in postmenopausal women with low bone mineral density (BMD) or mild osteoporosis through a randomized, open-label, parallel controlled trial with calcitriol as the control.
Postmenopausal women with low bone mineral density (BMD) or mild osteoporosis will be randomized in a 1:1 ratio to receive open-label oral 0.75ÎĽg eldecalcit daily or open-label oral 0.5ÎĽg calcitriol daily for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eldecalcitol | Experimental | Participants receive oral eldecalcitol 0.75ÎĽg daily for 12 months |
|
| Calcitriol | Active Comparator | Participants receive oral calcitriol 0.5ÎĽg daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eldecalcitol capsules | Drug | Oral eldecalcitol 0.75ÎĽg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline at Month 12 in BMD at the Lumbar Spine | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline at Month 6 in BMD at the Lumbar Spine | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. | Baseline to 6 months |
| Percent Change From Baseline at Month 6 in BMD of the Total Hip |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Shen | Contact | (+86)15800674978 | shenli_0510@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenlin Zhang | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Completed | Changsha | China | |||
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| Calcitriol capsules | Drug | Oral calcitriol 0.5ÎĽg daily |
|
|
Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. |
| Baseline to 6 months |
| Percent Change From Baseline at Month 6 in BMD of the Femoral Neck | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. | Baseline to 6 months |
| Percent Change From Baseline at Month 12 in BMD of the Total Hip | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. | Baseline to 6 months |
| Percent Change From Baseline at Month 12 in BMD of the Femoral Neck | Bone mineral density will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by a central imaging reader. | Baseline to 12 months |
| Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) | Serum P1NP will be determined | Baseline and months 6 and 12 |
| Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) | Serum CTX will be determined | Baseline and months 6 and 12 |
| Percent Change From Baseline in Parathyroid Hormone (PTH) | Serum PTH will be determined | Baseline and months 6 and 12 |
| Percent Change From Baseline in 25-Hydroxyvitamin D [25(OH)D] | Serum 25(OH)D will be determined | Baseline and months 6 and 12 |
| Incidence of new vertebral fracture | New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae | Baseline and months 12 |
| Zhejiang Provincial People's Hospital |
| Completed |
| Hangzhou |
| China |
| The Fourth Affiliated Hospital of Harbin Medical University | Recruiting | Ha’erbin | China |
|
| Huai 'an First People's Hospital | Completed | Huai'an | China |
| Liaocheng People's Hospital | Completed | Liaocheng | China |
| Jiangxi Provincial People's Hospital | Completed | Nanchang | China |
| Jiangsu Geriatric Hospital | Completed | Nanjin | China |
| The First Hospital of Ningbo | Completed | Ningbo | China |
| The Sixth Hospital of Ningbo | Completed | Ningbo | China |
| Pingxiang People's Hospital | Completed | Pingxiang | China |
| Huadong Hospital Affiliated to Fudan University | Completed | Shanghai | China |
| Shanghai First People's Hospital | Completed | Shanghai | China |
| Shanghai Pudong New Area Punan Hospital | Completed | Shanghai | China |
| Shanghai Sixth People's Hospital | Completed | Shanghai | China |
| Zhongshan Hosiptal Affiliated to Fudan University | Completed | Shanghai | China |
| The Second Affiliated Hospital of Soochow University | Completed | Suzhou | China |
| The First Hospital of Shanxi Medical University | Completed | Taiyuan | China |
| The Second Hospital of Shanxi Medical University | Completed | Taiyuan | China |
| Tianjin Hospital | Completed | Tianjin | China |
| Xi'an Honghui Hospital | Completed | Xi'an | China |
| Xuzhou Central Hospital | Completed | Xuzhou | China |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010024 | Osteoporosis |
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| ID | Term |
|---|---|
| C547512 | eldecalcitol |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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