Clinical trial NCT06837558: Predictors of Bone Mineral Density in Lupus Nephritis Activity
Official title: Predictors of Bone Mineral Density in Lupus Nephritis Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Mineral Density and Lupus Nephritis Activity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending outpatient clinics and inpatient of Internal Medicine department of Assiut University Hospital .The study will be done on total of 100 patients with SLE divided into:

(A): 50 Patients with SLE with lupus nephritis with activity (B): 50 Patients with SLE with lupus nephritis without activity

Brief summary: 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)

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

Primary outcomes:
measure: Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis
timeFrame: From 1/4/2025 to 1/4/2027
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut university hospital internal medicine
name: Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology
role: STUDY_CHAIR
References:
citation: Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315.