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NOT YET RECRUITING
NCT06385093
PHASE4

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Sponsor: Chinese SLE Treatment And Research Group

View on ClinicalTrials.gov

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

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

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