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