Bone Health in Patients With Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    60
  • sponsor
    Mayo Clinic
Updated on 15 March 2022
atopy

Summary

This study examines the bone health in children with atopic dermatitis

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.

Details
Condition Atopic Dermatitis, Eczema
Clinical Study IdentifierNCT03800004
SponsorMayo Clinic
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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