nctId: NCT06385093 id: EDR-IIS-003 briefTitle: A Study on the Prevention and Treatment of GIOP With Eldecalcitol acronym: ELEGANT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-04-25 date: 2024-04-25 name: Chinese SLE Treatment And Research Group class: OTHER name: Beijing Life oasis public service center briefSummary: 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. conditions: Rheumatoid Arthritis conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 314 type: ESTIMATED name: Eldecalcitol capsules name: Alfacalcidol tablets name: Calcium carbonate tablets measure: Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) measure: Percent change from baseline to month 6 in lumbar spine (L1-4) BMD measure: Percent change from baseline in total hip BMD measure: Percent change from baseline in femoral neck BMD measure: Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS) measure: Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP) measure: Percent change from baseline in Type 1 Collagen C-telopeptide (CTX) measure: Percentage of patients diagnosed with osteoporosis at month 12 measure: Incidence of new vertebral fracture measure: Change from baseline in Quality of Life assessed using EQ-5D-5L measure: Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) measure: Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score measure: Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Ying Jiang, MD role: CONTACT phone: +86-13391701765 email: jiangying@pumch.cn lat: 39.9075 lon: 116.39723 facility: Aerospace Central Hospital city: Beijing state: Beijing country: China name: Jian Liu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Luhe hospital, Capital Medical University city: Beijing state: Beijing country: China name: Baoyu Zhang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijingshan Hospital city: Beijing state: Beijing country: China name: Lian'na Xu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijitan Hospital city: Beijing state: Beijing country: China name: Yuhua Wang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shunyi hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing country: China name: Yi Zhao role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False