Bone Health in Patients With Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03800004|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 22, 2020
|Condition or disease|
|Atopic Dermatitis Eczema|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Bone Health in Patients With Atopic Dermatitis|
|Actual Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800004
|Contact: Henry Nguyen, MD||507-284-4673||Nguyen.Henry@mayo.edu|
|Contact: Katrina Pierce||507-266-1078||Pierce.Katrina@mayo.edu|
|Principal Investigator:||Megha M Tollefson, MD||Mayo Clinic|
|Study Director:||Henry Nguyen, MD||Mayo Clinic|