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

NCT05590390 | Active Not Recruiting

• 1 other identifier: 3875CESC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (12)

• Prevalence of osteoporosis

  percentage of patient with osteoporosis defined by WHO definition with T score

  1 visit - 1 hour

• Prevalence of fragility fractures

  percentage of patients with fragility fractures

  1 visit 1 hour

• EQ5D

  scores at questionnaire on quality of life EQ5D = EuroQol 5 dimension 5 L; (min 1-1-1-1-1, max 5-5-5-5-5 higher score worse + EQ VAS min 0, max 100 higher score better quality of life)

  1 visit - 1 hour

• FACIT-F

  scores in fatigue as for questionnaire FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue; min 0 - max 52, higher score less fatigue)

  1 visit - 1 hour

• SF-36 v2

  scores on quality of life with SF36 v2 (Short Form 36 version 2 Health Survey; min 0 - max 100, higher score better health)

  1 visit - 1 hour

• HADS

  scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)

  1 visit - 1 hour

• CQR5

  compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)

  1 visit - 1 hour

• PGA

  Patient global assessment ( VAS scale 0-10) higher score worse health

  1 visit - 1 hour

• influence of SLE medication - glucocorticoid

  The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in cumulative corticosteroid dose (mg)

  1 visit - 1 hour

• influence of SLE medication - hydroxychloroquine

  The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of hydroxychloroquine users.

  1 visit - 1 hour

• influence of SLE medication - immunosuppressant

  The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage percentage of immunosuppressant users

  1 visit - 1 hour

• influence of SLE medication - biologics

  The population will be analyzed grouping by presence or absence of fragility fracture in relation to medications variables such as difference in percentage of percentage of biologics ( e.g. belimumab) users.

  1 visit - 1 hour

Secondary Outcomes (15)

• Descriptive statistics of study population - 1

  1 visit - 1 hour

• Descriptive statistics of study population - 2

  1 visit - 1 hour

• Descriptive statistics of study population - 3

  1 visit - 1 hour

• Descriptive statistics of study population - 4

  1 visit - 1 hour

• serum bone biomarkers - BAP

  1 visit - 1 hour

Interventions

DXA DIAGNOSTIC_TEST

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

serum sample DIAGNOSTIC_TEST

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

PROs DIAGNOSTIC_TEST

questionnaires to investigate patients reported outcome on quality of life

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SLE patients 18-75 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona - UOC Reumatologia

Verona, 37134, Italy

Location

Related Publications (1)

• 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.

  PMID: 40953912 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maurizio Rossini, MD, PhD

  AOUI Verona - University of Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 21, 2022
• Study Start: December 31, 2022
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)