Bone Mineral Density and Lupus Nephritis ActivityNCT06837558
Predictors of Bone Mineral Density in Lupus Nephritis Activity
An observational study of Bone Mineral Density and Lupus Nephritis Activity, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Mineral Density and Lupus Nephritis Activity
- What is being tested?
- fibroblast growth factor 23
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Howaida Abel Hakim Nafady Nafady Hijo, professor of hematology contact
About this study
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
Read the 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)
- Being tested
- fibroblast growth factor 23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibroblast growth factor 23Diagnostic test
Also called DEXA bone scan
Investigations: including the different following modalititis
- Laboratory investigations include:
- Complete blood picture, PT PC INR, RBS Kidney function tests, eGFR Urine analysis, 24 hours' protein in urine
- 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)
- Imaging studies:
1 - Abdominal ultrasound 2- chest x-ray 3- Echocardiography (in lupus nephritis with activity form) 4- DEXA bone scan
- Invasive modality:
Renal biopsy of Patients with SLE with lupus nephritis
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Full history taking suggestion of SLE according to WHO criteria
- Complete physical examination (as blood pressure, pulse, chest, heart, abdomen examinations, lower limbs edema, puffiness of eyes)
- Investigations: including the different following modalititis
- Laboratory investigations include:
- Complete blood picture, PT PC INR, RBS Kidney function tests, eGFR Urine analysis, 24 hours' protein in urine
- 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)
- Imaging studies:
1 - Abdominal ultrasound 2- chest x-ray
Measured: From 1/4/2025 to 1/4/2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Mineral Density and Lupus Nephritis ActivityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar ahmed ammar, Assiut University
- Investigators
- Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology, Study chair, Assiut university hospital internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837558
- Sponsor's protocol ID
- Bone mass in lupus nephritis
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315.
PubMed 38587826
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Bone Mineral Density in Lupus Nephritis Activity
- ClinicalTrials.gov ID
- NCT06837558
- Acronym / sponsor ID
- Bone mass in lupus nephritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibroblast growth factor 23Also: DEXA bone scanInvestigations: 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 | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Results publication: PubMed 38587826Siegel CH, Sammaritano LR. Systemic Lupus Erythematosus: A Review. JAMA. 2024 May 7;331(17):1480-1491. doi: 10.1001/jama.2024.2315.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Howaida Abel Hakim Nafady Nafady Hijo, professor of hematology contact
Nashwa Moustafa Abdel Monem Azoz, assistant professor nephrology study chair
Assiut university hospital internal medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Mineral Density and Lupus Nephritis Activity, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ammar Ahmed Ammar Mohammed, Master degree internl medicine (00201120808217, Ammar1190@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From 1/4/2025 to 1/4/2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.