Predictors of Bone Mineral Density in Lupus Nephritis Activity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fibroblast growth factor 23.
- Who it may be relevant to
- Registry conditions: Bone Mineral Density and Lupus Nephritis Activity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Our aim in this study is Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis
Detailed description
Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by multisystem damage, leading to significant health issues \[1\]. There is growing concern over the adverse effects of medications used to treat SLE and the potential long-term complications \[2\]. Lupus nephritis (LN) is a severe and frequently manifestation of SLE, associated with significant morbidity and mortality \[3-5\]. Research indicates that female patients with SLE are at a higher risk of developing reduced bone mineral density (BMD) \[6-9\]. Moreover, women exhibit a high prevalence of osteoporosis and osteoporotic fractures \[10\]. Osteoporosis is a common and serious complication of SLE, contributing to increased morbidity and mortality rates \[11, 12\]. there is a notable gap in the literature regarding osteoporosis prevalence among LN patients. Risk factors such as glucocorticoid therapy, early menopause, and low calcium and vitamin D intake are known to contribute to bone loss \[13-16\], yet the specific risk factors associated with osteoporosis in LN patients vary by country, indicating a need for further research in this area. The pathophysiology of bone mineral density (BMD) reduction in Systemic Lupus Erythematosus (SLE), particularly in relation to lupus nephritis (LN) activity, is multifactorial and complex. The mechanisms behind this association involve immune system dysregulation, chronic inflammation, steroid use, kidney dysfunction, and alterations in mineral metabolism (17)
Interventions
- Diagnostic test fibroblast growth factor 23
Investigations: including the different following modalititis A. Laboratory investigations include: 1. Complete blood picture, PT PC INR, RBS Kidney function tests, eGFR Urine analysis, 24 hours' protein in urine 2. Specific laboratory investigations for SLE and lupus nephritis: ANA,AntiDsDNA,C3,C4 3. Laboratory investigations of Bone mineral density predictors Ca, phosphorus, PTH, vitamin D (OH), Alkaline phosphatase, Fibroblast Growth Factor 23 (FGF 23) B. Imaging studies: 1 - Abdominal ul
Primary outcome measures
- Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis [Time frame: From 1/4/2025 to 1/4/2027]
Eligibility criteria
Inclusion criteria
The patients with lupus nephritis based on KDIGO over 18 years and less than 60 years The patient diagnosed as SLE with lupus nephritis and in active form. The patient diagnosed as SLE with lupus nephritis and without active criteria The patient consent.
Exclusion criteria
Patients with SLE and also diagnosed as end stage renal disease on regular hemodialysis
- Association of another autoimmune as rheumatoid arthritis
- Association of HCV, HBV
- Association of diabetes mellitus or malignancy
- Patient had history of vitamin D supplementation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315. PMID 38587826
Identifiers
NCT: NCT06837558 · Bone mass in lupus nephritis