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| Name | Class |
|---|---|
| Beijing Life oasis public service center | UNKNOWN |
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The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients.
After having signed informed consent (Day 0), the patients will be screened for enrollment. About 314 eligible patients will be enrolled in this study. The background information of eligible patients including demographic characteristics, history of present illness, medical history, treatment history, etc., related questionnaire, baseline bone mineral density (BMD), X-ray examination result, High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) examination result, quantitative ultrasound (QUS) examination result and lab test result will be collected at Day 0. After enrollment, the following information will be collected at 6 months and/or 12 months: related questionnaire, BMD, X-ray examination result, HR-pQCT examination result, QUS examination result and lab test result, medication adherence and AE information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eldecalcitol | Experimental | Participants receive oral eldecalcitol 0.75μg daily for 12 months |
|
| Alfacalcidol + calcium carbonate | Active Comparator | Participants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eldecalcitol capsules | Drug | Oral eldecalcitol 0.75μg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) | BMD will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by blinded independent central review. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to month 6 in lumbar spine (L1-4) BMD | BMD will be measured using DXA. Images will be analyzed by blinded independent central review. | Baseline and 6 months |
| Percent change from baseline in total hip BMD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengtao Li, MD | Contact | +86-10-69158793 | mengtao.li@cstar.org.cn | |
| Ying Jiang, MD | Contact | +86-13391701765 | jiangying@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Mengtao Li, MD | Peking Union Medical College Hospital | Principal Investigator |
| Weibo Xia, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C547512 | eldecalcitol |
| C008088 | alfacalcidol |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Alfacalcidol tablets | Drug | Oral Alfacalcidol 0.5μg daily |
|
| Calcium carbonate tablets | Drug | 1.5g Calcium carbonate daily |
|
BMD will be measured using DXA. Images will be analyzed by blinded independent central review.
| Baseline, 6 months and 12 months |
| Percent change from baseline in femoral neck BMD | BMD will be measured using DXA. Images will be analyzed by blinded independent central review. | Baseline, 6 months and 12 months |
| Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS) | Broadband ultrasound attenuation (BUA) and speed of sound (SOS) will be measured by quantitative ultrasound (QUS). | Baseline and 12 months |
| Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP) | Serum P1NP will be tested | Baseline, 6 months and 12 months |
| Percent change from baseline in Type 1 Collagen C-telopeptide (CTX) | Serum CTX will be tested | Baseline, 6 months and 12 months |
| Percentage of patients diagnosed with osteoporosis at month 12 | Baseline and 12 months |
| Incidence of new vertebral fracture | New vertebral fracture will be confirmed by the lateral X-ray of thoracic/lumbar vertebrae | Baseline and 12 months |
| Change from baseline in Quality of Life assessed using EQ-5D-5L | The EQ-5D-5L represents a global quality of life measure that includes multiple components potentially impacted by the anti-anginal treatments being examined. The EQ-5D-5L score includes questions on mobility, self-care, usual activities, anxiety/depression, and pain/discomfort on a 5-point scale: 1=No Problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem, 5=Extreme Problem or Inability. 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively. Higher scores indicated greater levels of problems across each of the five dimensions. | Baseline, 6 months and 12 months |
| Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) | Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. | Baseline, 6 months and 12 months |
| Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score | DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. | Baseline, 6 months and 12 months |
| Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) | The vBMD includes several individual parameters as total volumetric bone mineral density (Tt.vBMD), trabecular volumetric bone density (Tb.vBMD), and cortical volumetric density (Ct.vBMD) which all in milligram/cubic centimetre. | Baseline and 12 months |
| Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) | The bone microarchitecture include several individual parameters as trabecular bone volume fraction (BV/TV) in %, trabecular number (Tb.N) in 1/millimeter, trabecular thickness (Tb.Th) in millimeter, trabecular separation (Tb.Sp) in millimeter, cortical thickness(Ct.Th) in millimeter, and cortical porosity (Ct.Po) in %. | Baseline and 12 months |
| Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) | The bone geometry include several individual parameters as total bone cross-sectional area (Tt.Ar), cortical area (Ct.Ar), and trabecular area (Tb.Ar) which all in square millimeter. | Baseline and 12 months |
| Ying Jiang, MD |
| Peking Union Medical College Hospital |
| Study Director |
| Aerospace Central Hospital | Beijing | Beijing Municipality | China |
|
| Beijing Luhe hospital, Capital Medical University | Beijing | Beijing Municipality | China |
|
| Beijing Shijingshan Hospital | Beijing | Beijing Municipality | China |
|
| Beijing Shijitan Hospital | Beijing | Beijing Municipality | China |
|
| Beijing Shunyi hospital | Beijing | Beijing Municipality | China |
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |