Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
- Conditions
- Lupus Erythematosus, Systemic
- Registration Number
- NCT05590390
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method influence of SLE medication - immunosuppressant 1 visit - 1 hour 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
influence of SLE medication - biologics 1 visit - 1 hour 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.
FACIT-F 1 visit - 1 hour scores in fatigue as for questionnaire FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue; min 0 - max 52, higher score less fatigue)
CQR5 1 visit - 1 hour compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)
PGA 1 visit - 1 hour Patient global assessment ( VAS scale 0-10) higher score worse health
Prevalence of osteoporosis 1 visit - 1 hour percentage of patient with osteoporosis defined by WHO definition with T score
EQ5D 1 visit - 1 hour 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)
influence of SLE medication - glucocorticoid 1 visit - 1 hour 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)
Prevalence of fragility fractures 1 visit 1 hour percentage of patients with fragility fractures
SF-36 v2 1 visit - 1 hour scores on quality of life with SF36 v2 (Short Form 36 version 2 Health Survey; min 0 - max 100, higher score better health)
HADS 1 visit - 1 hour scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)
influence of SLE medication - hydroxychloroquine 1 visit - 1 hour 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.
- Secondary Outcome Measures
Name Time Method serum bone biomarkers - OPG 1 visit - 1 hour OPG (pg/ml level) in study population and difference by fracture status
serum bone biomarkers - RANKL 1 visit - 1 hour RANKL (pg/ml) level in study population and difference by fracture status
serum bone biomarkers - BAP 1 visit - 1 hour bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status
serum bone biomarkers - CTX 1 visit - 1 hour C-terminal telopeptide of type I collagen (CTX) (ng/ml), level in study population and difference by fracture status
Descriptive statistics of study population - 1 1 visit - 1 hour The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to clinical variables - SLE disease duration
Descriptive statistics of study population - 2 1 visit - 1 hour The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to clinical variables - SDI ( SLICC Damage index - from 0, higher score higher disease damage accrual)
serum bone biomarkers - P1NP 1 visit - 1 hour N-terminal propeptide of type I procollagen - P1NP (ng/ml) level in study population and difference by fracture status
serum bone biomarkers - Dkk1 1 visit - 1 hour Dkk1 (pmol/L) level in study population and difference by fracture status
Fracture risk calculation by DEFRA tool 1 visit - 1 hour DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)
serum bone biomarkers - Sclerostin 1 visit - 1 hour sclerostin (pmol/L) level in study population and difference by fracture status
Fracture risk calculation by FRAX tool 1 visit - 1 hour FRAX fracture risk assessment ( % risk major fracture in 10 yrs)
Descriptive statistics of study population - 3 1 visit - 1 hour The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - Age ( years)
Descriptive statistics of study population - 4 1 visit - 1 hour The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - gender ( % females)
serum bone biomarkers - PTH 1 visit - 1 hour parathormone (PTH) pg/ml level in study population and difference by fracture status
serum bone biomarkers - vitamin D(OH) 1 visit - 1 hour 25OH vitamin D (ng/ml), level in study population and difference by fracture status
Trial Locations
- Locations (1)
AOUI Verona - UOC Reumatologia
🇮🇹Verona, Italy