Trials / Active Not Recruiting
Active Not RecruitingNCT05590390
Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
Prevalence and Impact on Quality of Life of Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | DXA | bone densitometry at lumbar and femoral site+ morphometry (DXA), |
| DIAGNOSTIC_TEST | serum sample | serum samples for bone biomarkers ( eg. P1NP, CTX, Dkk-1, etc) |
| DIAGNOSTIC_TEST | PROs | questionnaires to investigate patients reported outcome on quality of life |
Timeline
- Start date
- 2022-12-31
- Primary completion
- 2024-10-30
- Completion
- 2024-12-30
- First posted
- 2022-10-21
- Last updated
- 2024-08-06
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05590390. Inclusion in this directory is not an endorsement.