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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 visit - 1 hour |
| Descriptive statistics of study population - 2 |
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Inclusion Criteria:
Exclusion Criteria:
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SLE patients 18-75 years
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Rossini, MD, PhD | AOUI Verona - University of Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUI Verona - UOC Reumatologia | Verona | 37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953912 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 10, 2024 | |
| Unrelease | Dec 10, 2024 | |
| Release | Dec 11, 2024 | |
| Reset | Jan 24, 2025 | |
| Release | Nov 18, 2025 | |
| Reset | Dec 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 10, 2024 | Dec 10, 2024 | |||
| Dec 11, 2024 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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serum samples
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 |
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) |
| 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) | 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) | 1 visit - 1 hour |
| serum bone biomarkers - BAP | bone alkaline phosphatase (BAP) (ug/L) level in study population and difference by fracture status | 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 | 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 | 1 visit - 1 hour |
| serum bone biomarkers - PTH | parathormone (PTH) pg/ml level in study population and difference by fracture status | 1 visit - 1 hour |
| serum bone biomarkers - vitamin D(OH) | 25OH vitamin D (ng/ml), level in study population and difference by fracture status | 1 visit - 1 hour |
| serum bone biomarkers - Sclerostin | sclerostin (pmol/L) level in study population and difference by fracture status | 1 visit - 1 hour |
| serum bone biomarkers - Dkk1 | Dkk1 (pmol/L) level in study population and difference by fracture status | 1 visit - 1 hour |
| serum bone biomarkers - RANKL | RANKL (pg/ml) level in study population and difference by fracture status | 1 visit - 1 hour |
| serum bone biomarkers - OPG | OPG (pg/ml level) in study population and difference by fracture status | 1 visit - 1 hour |
| Fracture risk calculation by FRAX tool | FRAX fracture risk assessment ( % risk major fracture in 10 yrs) | 1 visit - 1 hour |
| Fracture risk calculation by DEFRA tool | DEFRA fracture risk assessment ( % risk major fracture in 10 yrs) | 1 visit - 1 hour |
| Jan 24, 2025 |
| Nov 18, 2025 | Dec 8, 2025 |