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.
Study Type
OBSERVATIONAL
Enrollment
300
bone densitometry at lumbar and femoral site+ morphometry (DXA),
serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc)
questionnaires to investigate patients reported outcome on quality of life
AOUI Verona - UOC Reumatologia
Verona, Italy
Prevalence of osteoporosis
percentage of patient with osteoporosis defined by WHO definition with T score
Time frame: 1 visit - 1 hour
Prevalence of fragility fractures
percentage of patients with fragility fractures
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 visit - 1 hour
HADS
scores on mood disorder scale HADS (Health Anxiety and Depression Scale; min 0 - Max 42, higher score worse anxiety)
Time frame: 1 visit - 1 hour
CQR5
compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)
Time frame: 1 visit - 1 hour
PGA
Patient global assessment ( VAS scale 0-10) higher score worse health
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 visit - 1 hour
Descriptive statistics of study population - 1
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
Time frame: 1 visit - 1 hour
Descriptive statistics of study population - 2
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)
Time frame: 1 visit - 1 hour
Descriptive statistics of study population - 3
The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - Age ( years)
Time frame: 1 visit - 1 hour
Descriptive statistics of study population - 4
The population will be analyzed as whole and also grouping by presence or absence of fragility fracture in relation to demographic variable - gender ( % females)
Time frame: 1 visit - 1 hour
serum bone biomarkers - BAP
bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - P1NP
N-terminal propeptide of type I procollagen - P1NP (ng/ml) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - CTX
C-terminal telopeptide of type I collagen (CTX) (ng/ml), level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - PTH
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parathormone (PTH) pg/ml level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - vitamin D(OH)
25OH vitamin D (ng/ml), level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - Sclerostin
sclerostin (pmol/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - Dkk1
Dkk1 (pmol/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - RANKL
RANKL (pg/ml) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
serum bone biomarkers - OPG
OPG (pg/ml level) in study population and difference by fracture status
Time frame: 1 visit - 1 hour
Fracture risk calculation by FRAX tool
FRAX fracture risk assessment ( % risk major fracture in 10 yrs)
Time frame: 1 visit - 1 hour
Fracture risk calculation by DEFRA tool
DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)
Time frame: 1 visit - 1 hour