Predictors of Bone Mineral Density in Lupus Nephritis Activity

NCT ID: NCT06837558

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-05-01

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)

Conditions

Bone Mineral Density and Lupus Nephritis Activity

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

lupus nephritis in active form

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 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 3- Echocardiography (in lupus nephritis with acti

fibroblast growth factor 23

Intervention Type: DIAGNOSTIC_TEST

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 3- Echocardiography (in lupus nephritis with activity form) 4- DEXA bone scan

C. Invasive modality:

Renal biopsy of Patients with SLE with lupus nephritis

lupus nephritis in inactive form

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 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 3- Echocardiography (in lupus nephritis with acti

fibroblast growth factor 23

Intervention Type: DIAGNOSTIC_TEST

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 3- Echocardiography (in lupus nephritis with activity form) 4- DEXA bone scan

C. Invasive modality:

Renal biopsy of Patients with SLE with lupus nephritis

Interventions

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 ultrasound 2- chest x-ray 3- Echocardiography (in lupus nephritis with activity form) 4- DEXA bone scan

C. Invasive modality:

Renal biopsy of Patients with SLE with lupus nephritis

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

DEXA bone scan

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ammar ahmed ammar

Assiut university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology

Role: STUDY_CHAIR

Assiut university hospital internal medicine

Central Contacts

Ammar Ahmed Ammar Mohammed, Master degree internl medicine

Role: CONTACT

Ammar1190@yahoo.com

00201120808217

Howaida Abel Hakim Nafady Nafady Hijo, professor of hematology

Role: CONTACT

howaida.nafady3@gmail.com

00201094721339

References

Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315.

Reference Type: BACKGROUND

PMID: 38587826 (View on PubMed)

Other Identifiers

Bone mass in lupus nephritis

Identifier Type: -

Identifier Source: org_study_id