Overview

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Status:
NOT_YET_RECRUITING
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Chinese SLE Treatment And Research Group
Collaborator:
Beijing Life oasis public service center
Treatments:
alfacalcidol
Calcium Carbonate
eldecalcitol