Bone Mineral Density in Patients with Childhood-onset Systemic Lupus Erythematous, in Relation to Disease Clinical Criteria

NCT06586359 | Not Yet Recruiting

• 1 other identifier: childhood-onset systemic lupus
• Study Type: observational
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

• To determine the most common clinical characteristics in patients with childhood -onset systemic lupus erythematosus.
• To detect prevalence of low bone mineral density in patients with childhood -onset systemic lupus erythematosus.

Conditions

Systemic Lupus Erthematosus

Outcome Measures

Primary Outcomes (1)

• Detection of prevalence of low bone mineral density and clinical characteristics in patients with childhood -onset systemic lupus erythematosus

  There is association between SlE and bone mineral density. Possible factors contributing to low bone mineral density in CSLE patients include chronic inflammation, glucocorticoid therapy, and the presence of various cytokines produced by immune cells that interfere with bone homeostasis. Lifestyle factors and low vitamin D levels in CSLE patients may further contribute to the risk of osteoporosis

  Baseline

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Patients diagnosed as SLE, according to 2019 European league against rheumatism (EULAR)/ American college of rheumatology (ACR) SLE classification criteria from \>6 months ago.

You may qualify if:

• Age of patients below 18 years old.
• Both sexes.
• The Patients should be diagnosed as SLE, according to 2019 European league against rheumatism (EULAR)/ American college of rheumatology (ACR) SLE classification criteria from \>6 months ago.

You may not qualify if:

• Patients with autoimmune diseases other than CSLE.
• Patients not fulfilling the criteria for diagnosis of CSLE.
• Active infections.
• Malignancies.
• Patients with other diseases which decrease vitamin D levels as malabsorption, cholestatic jaundice and chronic kidney disease.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Kiriakidou M, Ching CL. Systemic Lupus Erythematosus. Ann Intern Med. 2020 Jun 2;172(11):ITC81-ITC96. doi: 10.7326/AITC202006020.

  PMID: 32479157 BACKGROUND

• Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.

  PMID: 31385462 BACKGROUND

• Tian J, Zhang D, Yao X, Huang Y, Lu Q. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82(3):351-356. doi: 10.1136/ard-2022-223035. Epub 2022 Oct 14.

  PMID: 36241363 BACKGROUND

Central Study Contacts

Mohammed Shehata Abdelmohsen Issa, Bachelor of Medicine

CONTACT

01096987787; moshehata9963@gmail.com

Naglaa Samy Mohamed Osman, Associate professor

CONTACT

01002673103; Naglaaosman84@edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09