Clinical trial NCT05590390: Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Official title: Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SLE patients 18-75 years

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.


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.

Primary outcomes:
measure: Prevalence of osteoporosis
timeFrame: 1 visit - 1 hour
measure: Prevalence of fragility fractures
timeFrame: 1 visit 1 hour
measure: EQ5D
timeFrame: 1 visit - 1 hour
measure: FACIT-F
timeFrame: 1 visit - 1 hour
measure: SF-36 v2
timeFrame: 1 visit - 1 hour
measure: HADS
timeFrame: 1 visit - 1 hour
measure: CQR5
timeFrame: 1 visit - 1 hour
measure: PGA
timeFrame: 1 visit - 1 hour
measure: influence of SLE medication - glucocorticoid
timeFrame: 1 visit - 1 hour
measure: influence of SLE medication - hydroxychloroquine
timeFrame: 1 visit - 1 hour
measure: influence of SLE medication - immunosuppressant
timeFrame: 1 visit - 1 hour
measure: influence of SLE medication - biologics
timeFrame: 1 visit - 1 hour
Secondary outcomes:
measure: Descriptive statistics of study population - 1
timeFrame: 1 visit - 1 hour
measure: Descriptive statistics of study population - 2
timeFrame: 1 visit - 1 hour
measure: Descriptive statistics of study population - 3
timeFrame: 1 visit - 1 hour
measure: Descriptive statistics of study population - 4
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - BAP
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - P1NP
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - CTX
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - PTH
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - vitamin D(OH)
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - Sclerostin
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - Dkk1
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - RANKL
timeFrame: 1 visit - 1 hour
measure: serum bone biomarkers - OPG
timeFrame: 1 visit - 1 hour
measure: Fracture risk calculation by FRAX tool
timeFrame: 1 visit - 1 hour
measure: Fracture risk calculation by DEFRA tool
timeFrame: 1 visit - 1 hour
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - UOC Reumatologia
Study officials:
affiliation: AOUI Verona - University of Verona
name: Maurizio Rossini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: