NCT06385093

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Chinese SLE Treatment And Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis
• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DRUG	Eldecalcitol capsules	Oral eldecalcitol 0.75μg daily
DRUG	Alfacalcidol tablets	Oral Alfacalcidol 0.5μg daily
DRUG	Calcium carbonate tablets	1.5g Calcium carbonate daily

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

7 sites across 1 country: China