Bone Health in Patients With Atopic Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score
Study Overview
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:
- 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.
- HR-pQCT data will be compared with current known data from other diseases
- To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores.
- To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score
Time Frame: 2 years
To 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 markers
Time Frame: 2 years
To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers
Correlate bone mineral density to normative data
Time Frame: 2 years
To 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Megha M. Tollefson, M.D.
Principal Investigator
Mayo Clinic