Predictors of Bone Mineral Density in Lupus Nephritis Activity

February 15, 2025 updated by: Ammar ahmed ammar, Assiut University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ammar Ahmed Ammar Mohammed, Master degree internl medicine
  • Phone Number: 00201120808217
  • Email: Ammar1190@yahoo.com

Study Contact Backup

  • Name: Howaida Abel Hakim Nafady Nafady Hijo, professor of hematology
  • Phone Number: 00201094721339
  • Email: howaida.nafady3@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

Other Names:
  • DEXA bone scan
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

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

Other Names:
  • DEXA bone scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology, Assiut university hospital internal medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bone mass in lupus nephritis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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