Predictors of Bone Mineral Density in Lupus Nephritis Activity

NCT06837558 | Not Yet Recruiting

• 1 other identifier: Bone mass in lupus nephritis
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bone Mineral Density and Lupus Nephritis Activity

Outcome Measures

Primary Outcomes (1)

• Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis

  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

  From 1/4/2025 to 1/4/2027

Study Arms (2)

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

Diagnostic Test: fibroblast growth factor 23

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

Diagnostic Test: fibroblast growth factor 23

Interventions

fibroblast growth factor 23 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

Also known as: DEXA bone scan

lupus nephritis in active form; lupus nephritis in inactive form

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology

  Assiut university hospital internal medicine

  STUDY CHAIR

Central Study Contacts

Ammar Ahmed Ammar Mohammed, Master degree internl medicine

CONTACT

00201120808217; Ammar1190@yahoo.com

Howaida Abel Hakim Nafady Nafady Hijo, professor of hematology

CONTACT

00201094721339; howaida.nafady3@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut university

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02