Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-09
Brief Title:
A Study on the Prevention and Treatment of GIOP With Eldecalcitol
Sponsor:
Chinese SLE Treatment And Research Group
Organization:
Chinese SLE Treatment And Research Group
Study Overview
Official Title:
Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients ELEGANT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELEGANT
Brief 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 11 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None