Predictors of Bone Mineral Density in Lupus Nephritis Activity

Not yet recruiting

• Conditions: Bone Mineral Density and Lupus Nephritis Activity

• Registration Number: NCT06837558
• Lead Sponsor: Assiut University

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)

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-04-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis	From 1/4/2025 to 1/4/2027	All patients in this study will be subjected to: 1. Full history taking suggestion of SLE according to WHO criteria; 2. Complete physical examination (as blood pressure, pulse, chest, heart, abdomen examinations, lower limbs edema, puffiness of eyes); 3. 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 ultrasound 2- chest x-ray