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

NCT05590390 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Maurizio Rossini, MD, PhD · AOUI Verona - University of Verona

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-10-30
Completion
2024-12-30

Countries

  • Italy

Study Locations

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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 NCT05590390 on ClinicalTrials.gov