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A Study on the Prevention and Treatment of GIOP With Eldecalcitol
Sponsor: Chinese SLE Treatment And Research Group
Summary
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.
Official title: Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2024-06
Completion Date
2026-03
Last Updated
2024-04-25
Healthy Volunteers
No
Interventions
Eldecalcitol capsules
Oral eldecalcitol 0.75μg daily
Alfacalcidol tablets
Oral Alfacalcidol 0.5μg daily
Calcium carbonate tablets
1.5g Calcium carbonate daily
Locations (7)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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