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A Study on the Prevention and Treatment of GIOP With Eldecalcitol

NCT06385093 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Beijing Life oasis public service center

    collaborator UNKNOWN

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Mengtao Li, MD · Peking Union Medical College Hospital

  • Weibo Xia, MD · Peking Union Medical College Hospital

  • Ying Jiang, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385093 on ClinicalTrials.gov