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

Integrated University Hospital Trust of Verona

Status: Active, not recruiting

Conditions: Lupus Erythematosus, Systemic

Treatments: Diagnostic Test: PROs; Diagnostic Test: serum sample; Diagnostic Test: DXA

Study type: Observational

Funder types: Other

Identifiers

NCT05590390

3875CESC

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SLE fulfilling 2019 ACR/EULAR or 2012 SLICC criteria
• willing to perform DXA/ x-Ray investigation (common clinical practice)
• willing to donate blood sample
• willing to complete questionnaires
• the patients should be in a stable disease activity.

Exclusion criteria

• Uncontrolled endocrinological disease.
• metabolic bone disease other than osteoporosis ( e.g. Paget disease).
• celiac disease, inflammatory bowel disease or pancreatic exocrine deficiency resulting in malabsorption
• patients lacking medication history information (SLE and bone related medications).
• Have any other clinically significant abnormal laboratory value in the opinion of the investigator
• Have any intercurrent significant medical illness that the investigator considers would make the candidate unsuitable for the study.
• The patients shouldn't be enrolled during a moderate to severe flare of disease requiring an escalation of therapy ( especially glucocorticoid) - no new BILAG A or B in the last 3 months.
• Pregnant patients or during the first year after child birth.