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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
Sponsor:
Collaborator:
Pediatric Dermatology Research Alliance
Information provided by (Responsible Party):
Megha M. Tollefson, M.D., Mayo Clinic

Brief Summary:
This study examines the bone health in children with atopic dermatitis

Condition or disease
Atopic Dermatitis Eczema

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Henry Nguyen, MD 507-284-4673 Nguyen.Henry@mayo.edu
Contact: Katrina Pierce 507-266-1078 Pierce.Katrina@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55906
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         
Sponsors and Collaborators
Mayo Clinic
Pediatric Dermatology Research Alliance
Investigators
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Principal Investigator: Megha M Tollefson, MD Mayo Clinic
Study Director: Henry Nguyen, MD Mayo Clinic

Additional Information:
Publications:
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Responsible Party: Megha M. Tollefson, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03800004    
Other Study ID Numbers: 17-007112
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Megha M. Tollefson, M.D., Mayo Clinic:
Bone Health
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases