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

NCT ID: NCT05590390

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

DXA

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

Intervention Type: DIAGNOSTIC_TEST

serum sample

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

Intervention Type: DIAGNOSTIC_TEST

PROs

questionnaires to investigate patients reported outcome on quality of life

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Rossini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AOUI Verona - University of Verona

Locations

AOUI Verona - UOC Reumatologia

Verona, , Italy

Countries

Italy

References

Rotta D, Adami G, Galvagni I, Pistillo F, Fassio A, Gatti D, Zen M, Ravagnani V, Maiolini F, Croce J, Volpe A, Dartizio C, Benini C, Ruzzon F, Viapiana O, Rossini M, Orsolini G. Prevalence and determinants of vertebral fractures in a SLE cohort. Lupus Sci Med. 2025 Sep 14;12(2):e001508. doi: 10.1136/lupus-2025-001508.

Reference Type: DERIVED

PMID: 40953912 (View on PubMed)

Other Identifiers

3875CESC

Identifier Type: -

Identifier Source: org_study_id