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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

Tracking Information
First Submitted Date January 8, 2019
First Posted Date January 10, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date July 30, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Health in Patients With Atopic Dermatitis
Official Title Bone Health in Patients With Atopic Dermatitis
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist
Condition
  • Atopic Dermatitis
  • Eczema
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Henry Nguyen, MD 507-284-4673 Nguyen.Henry@mayo.edu
Contact: Katrina Pierce 507-266-1078 Pierce.Katrina@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03800004
Other Study ID Numbers 17-007112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Megha M. Tollefson, M.D., Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Pediatric Dermatology Research Alliance
Investigators
Principal Investigator: Megha M Tollefson, MD Mayo Clinic
Study Director: Henry Nguyen, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2020