AOUI Verona - UOC Reumatologia
Verona, 37134, Italy
NCT Number: NCT05590390
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–75 year
All sexes
Observational
Verona, 37134, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 visit - 1 hour
percentage of patient with osteoporosis defined by WHO definition with T score
Time frame: 1 visit 1 hour
percentage of patients with fragility fractures
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 visit - 1 hour
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
compliance questionnaire in rheumatology 5 items; adherent - not adherent to medication)
Time frame: 1 visit - 1 hour
Patient global assessment ( VAS scale 0-10) higher score worse health
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 visit - 1 hour
bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
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
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
parathormone (PTH) pg/ml level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
25OH vitamin D (ng/ml), level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
sclerostin (pmol/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
Dkk1 (pmol/L) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
RANKL (pg/ml) level in study population and difference by fracture status
Time frame: 1 visit - 1 hour
OPG (pg/ml level) in study population and difference by fracture status
Time frame: 1 visit - 1 hour
FRAX fracture risk assessment ( % risk major fracture in 10 yrs)
Time frame: 1 visit - 1 hour
DEFRA fracture risk assessment ( % risk major fracture in 10 yrs)
Azienda Ospedaliera Universitaria Integrata Verona
Other
Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Acronym: FRAIL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05648500
Autoimmune Diseases, Connective Tissue Diseases
Huntington Park, California, United States
View Trial DetailsNCT05672576
Autoimmune Diseases, Connective Tissue Diseases
Tucson, Arizona, United States
View Trial DetailsNCT07381465
Autoimmune Diseases, Connective Tissue Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT05141201
Autoimmune Diseases, Connective Tissue Diseases
Aichi, Japan
View Trial Details