Clinical Trial

Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)

Study acronym: FRAIL
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 6, 2024 (before its estimated October 30, 2024 completion). Its status may not reflect the trial's current state.
Summary
The trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of SLE patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, DMARDs or belimumab. Patients will perform DXA evaluation, blood tests and PROs questionnaires. Moreover, the investigators want to correlate those variables to bone turnover markers and bone metabolism modulators. A secondary aim is also to assess the fracture risk of those patients as described by FRAX and DEFRA tools.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-18; most recent amendment 2024-08-05.
Status change: Recruiting → Active, Not Recruiting 2024-08-05
Trial Details
NCT Number NCT05590390
Lead Sponsor Azienda Ospedaliera Universitaria Integrata Verona
Conditions Lupus Erythematosus, Systemic
Enrollment 300 participants
Start Date 2022-12-31
Primary Completion 2024-10-30 (estimated)
Study Completion 2024-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-06