Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 314
- 试验地点
- 7
- 主要终点
- Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult rheumatoid arthritis patients(≥18 years) who fulfilled the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria.
- •Had been taking 5-10 mg oral prednisolone (or equivalent) daily glucocorticoids for longer than 3 months at screening and were expected to receive glucocorticoids for at least another 12 months.
- •Ambulant outpatients
- •Written informed consent
排除标准
- •BMD T<-3.0 measured by DXA at screening
- •Vertebral, hip, proximal humerus, pelvis, or distal forearm fragility fracture history
- •Any severe bone disorder or deformation at the lumbar spine that would affect DXA measurement
- •Primary hyperparathyroidism, Cushing's syndrome, hyperthyroidism, gonadal insufficiency, osteogenesis impotence, poorly controlled diabetes mellitus (HbA1c>9%), or other diseases that can affect bone metabolism
- •Had injected bisphosphonate once or more within 3 years before entering the study; or had received oral bisphosphonate 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 selective estrogen receptor modulator or hormone replacement therapy or traditional Chinese medicine for osteoporosis within 2 months prior to study entry; or received active vitamin D within 2 weeks prior to study entry; or received subcutaneous anti-RANKL antibody at any time prior to study entry
- •Urolithiasis at screening or had a history of urolithiasis
- •Hypercalcemia (serum calcium >10.4 mg/dL), or hypercalciuria (fasting morning urine calcium/creatinine >400 mg/gCr or 24h urine calcium >300mg), or had serum creatinine levels above the reference range
- •Severe liver disease such as cirrhosis or serious heart disease such as severe heart failure
- •Active malignant tumors or a history of malignant tumors within 5 years before informed consent obtained
- •History of allergy to vitamin D
- •Pregnant women or female patients planning to become pregnant during the study
- •Other inappropriate situations judged by investigators
研究组 & 干预措施
Eldecalcitol
Participants receive oral eldecalcitol 0.75μg daily for 12 months
干预措施: Eldecalcitol capsules (Drug)
Alfacalcidol + calcium carbonate
Participants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months
干预措施: Alfacalcidol tablets (Drug)
Alfacalcidol + calcium carbonate
Participants receive oral calcitriol 0.5μg daily and 1.5g calcium carbonate daily for 12 months
干预措施: Calcium carbonate tablets (Drug)
结局指标
主要结局
Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD)
时间窗: Baseline and 12 months
BMD will be measured using dual energy x-ray absorptiometry (DXA). Images will be analyzed by blinded independent central review.
次要结局
- Percent change from baseline to month 6 in lumbar spine (L1-4) BMD(Baseline and 6 months)
- Percent change from baseline in total hip BMD(Baseline, 6 months and 12 months)
- Percent change from baseline in femoral neck BMD(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)(Baseline and 12 months)
- Percent change from baseline in Type 1 Collagen C-telopeptide (CTX)(Baseline, 6 months and 12 months)
- Percentage of patients diagnosed with osteoporosis at month 12(Baseline and 12 months)
- Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP)(Baseline, 6 months and 12 months)
- Incidence of new vertebral fracture(Baseline and 12 months)
- Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score(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)(Baseline and 12 months)
- Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)(Baseline and 12 months)
- Change from baseline in Quality of Life assessed using EQ-5D-5L(Baseline, 6 months and 12 months)
- Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, 6 months and 12 months)
- Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT)(Baseline and 12 months)
研究者
Mengtao Li
Professor and Director, Rheumatology and Immunology Department
Peking Union Medical College Hospital