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Bone Health in Patients With Atopic Dermatitis

Bone Health in Patients With Atopic Dermatitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03800004
Enrollment
30
Registered
2019-01-10
Start date
2018-07-30
Completion date
2024-07-16
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

Keywords

Bone Health

Brief summary

This study examines the bone health in children with atopic dermatitis

Detailed description

The goal of this study is to objectively evaluate bone health and contributing factors in children with AD. This will be compared with existing normative data. Such an objective prospective study, directly looking at bone health in children has not yet been done. This will be done using bone densitometry (DXA) and high-resolution peripheral quantitative computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status. HR-pQCT is a cutting-edge technology available at only at a few academic centers in the United States that is used to measure bone strength with minimal doses of radiation. In addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. The results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care. The specific aims of this project are: 1. To determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using DXA and to compare this with normative data. 2. HR-pQCT data will be compared with current known data from other diseases 3. To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores. 4. To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.

Interventions

None listed

Sponsors

Pediatric Dermatology Research Alliance
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist * Duration of atopic dermatitis symptoms for a minimum of 6 months * Ability to cooperate with DXA and HR-pQCT procedure

Exclusion criteria

* Those without a confirmed diagnosis of moderate to severe atopic dermatitis * Presence of concurrent disease that may also affect bone health, including rickets or other vitamin D deficiency, thyroid disease, renal disease, Paget's disease, osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory diseases * Current use of medications that may affect bone health, including bisphosphonate, Forteo, Tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate, cyclosporine, and oral tacrolimus. However, medications that are used for atopic dermatitis treatment are allowed * Pregnant or breast feeding females * Inability to cooperate with the blood draw

Design outcomes

Primary

MeasureTime frameDescription
Correlate bone mineral density to normative data2 yearsTo determine bone mineral density (BMD) and cortical and trabecular bone strength in children with atopic dermatitis, using dual energy x-ray absorptiometry (DXA) and High-resolution peripheral quantitative computed tomography (HR-pQCT) and to compare this with normative data.
Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score2 yearsTo correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores
Correlate bone age with serum markers2 yearsTo determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026