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Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
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.
Official title: Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2022-12-31
Completion Date
2024-12-30
Last Updated
2024-08-06
Healthy Volunteers
No
Conditions
Interventions
DXA
bone densitometry at lumbar and femoral site+ morphometry (DXA),
serum sample
serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc)
PROs
questionnaires to investigate patients reported outcome on quality of life
Locations (1)
AOUI Verona - UOC Reumatologia
Verona, Italy