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ACTIVE NOT RECRUITING
NCT05590390

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

Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

DXA

bone densitometry at lumbar and femoral site+ morphometry (DXA),

DIAGNOSTIC_TEST

serum sample

serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc)

DIAGNOSTIC_TEST

PROs

questionnaires to investigate patients reported outcome on quality of life

Locations (1)

AOUI Verona - UOC Reumatologia

Verona, Italy