<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800004</url>
  </required_header>
  <id_info>
    <org_study_id>17-007112</org_study_id>
    <nct_id>NCT03800004</nct_id>
  </id_info>
  <brief_title>Bone Health in Patients With Atopic Dermatitis</brief_title>
  <official_title>Bone Health in Patients With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pediatric Dermatology Research Alliance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the bone health in children with atopic dermatitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to objectively evaluate bone health and contributing factors in&#xD;
      children with AD. This will be compared with existing normative data. Such an objective&#xD;
      prospective study, directly looking at bone health in children has not yet been done. This&#xD;
      will be done using bone densitometry (DXA) and high-resolution peripheral quantitative&#xD;
      computed tomography (HR-pQCT) for the accurate and precise measurement of bone health status.&#xD;
      HR-pQCT is a cutting-edge technology available at only at a few academic centers in the&#xD;
      United States that is used to measure bone strength with minimal doses of radiation. In&#xD;
      addition, blood and urine metabolic parameters related to bone health will be analyzed, and&#xD;
      data will be correlated with eczema severity. The results from this study will allow us to&#xD;
      design large-scale, multi-institutional studies on bone health in this population and&#xD;
      ultimately to guide decision making in children who may be at risk specifically regarding&#xD;
      treatment recommendations and supportive care.&#xD;
&#xD;
      The specific aims of this project are:&#xD;
&#xD;
        1. To determine bone mineral density (BMD) and cortical and trabecular bone strength in&#xD;
           children with atopic dermatitis, using DXA and to compare this with normative data.&#xD;
&#xD;
        2. HR-pQCT data will be compared with current known data from other diseases&#xD;
&#xD;
        3. To correlate bone mineral density with eczema severity using Eczema area and severity&#xD;
           index (EASI) and Scoring atopic dermatitis (SCORAD) scores.&#xD;
&#xD;
        4. To determine if bone mineral density in children with atopic dermatitis correlates with&#xD;
           bone age and bone-health specific serum markers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 30, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlate bone mineral density to normative data</measure>
    <time_frame>2 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score</measure>
    <time_frame>2 years</time_frame>
    <description>To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlate bone age with serum markers</measure>
    <time_frame>2 years</time_frame>
    <description>To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers</description>
  </primary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Eczema</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children with a diagnosis of moderate to severe atopic dermatitis as made by a&#xD;
        dermatologist&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis&#xD;
             as made by a dermatologist&#xD;
&#xD;
          -  Duration of atopic dermatitis symptoms for a minimum of 6 months&#xD;
&#xD;
          -  Ability to cooperate with DXA and HR-pQCT procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those without a confirmed diagnosis of moderate to severe atopic dermatitis&#xD;
&#xD;
          -  Presence of concurrent disease that may also affect bone health, including rickets or&#xD;
             other vitamin D deficiency, thyroid disease, renal disease, Paget's disease,&#xD;
             osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory&#xD;
             diseases&#xD;
&#xD;
          -  Current use of medications that may affect bone health, including bisphosphonate,&#xD;
             Forteo, Tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate,&#xD;
             cyclosporine, and oral tacrolimus. However, medications that are used for atopic&#xD;
             dermatitis treatment are allowed&#xD;
&#xD;
          -  Pregnant or breast feeding females&#xD;
&#xD;
          -  Inability to cooperate with the blood draw&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megha M Tollefson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henry Nguyen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Henry Nguyen, MD</last_name>
    <phone>507-284-4673</phone>
    <email>Nguyen.Henry@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Katrina Pierce</last_name>
    <phone>507-266-1078</phone>
    <email>Pierce.Katrina@mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55906</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henry Nguyen, MD</last_name>
      <phone>507-284-4673</phone>
      <email>Nguyen.Henry@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Katrina Pierce</last_name>
      <phone>507-266-1078</phone>
      <email>pierce.katrina@mayo.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Megha M Tollefson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <reference>
    <citation>Garg N, Silverberg JI. Association between eczema and increased fracture and bone or joint injury in adults: a US population-based study. JAMA Dermatol. 2015 Jan;151(1):33-41. doi: 10.1001/jamadermatol.2014.2098.</citation>
    <PMID>25353616</PMID>
  </reference>
  <reference>
    <citation>Haeck IM, Hamdy NA, Timmer-de Mik L, Lentjes EG, Verhaar HJ, Knol MJ, de Bruin-Weller MS, Bruijnzeel-Koomen CA. Low bone mineral density in adult patients with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Dec;161(6):1248-54. doi: 10.1111/j.1365-2133.2009.09327.x. Epub 2009 Jun 4.</citation>
    <PMID>19673879</PMID>
  </reference>
  <reference>
    <citation>van Velsen SG, Knol MJ, van Eijk RL, de Vroede MA, de Wit TC, Lam MG, Haeck IM, de Bruin-Weller MS, Bruijnzeel-Koomen CA, Pasmans SG. Bone mineral density in children with moderate to severe atopic dermatitis. J Am Acad Dermatol. 2010 Nov;63(5):824-31. doi: 10.1016/j.jaad.2009.12.015. Epub 2010 Sep 17.</citation>
    <PMID>20850893</PMID>
  </reference>
  <reference>
    <citation>Wu CY, Lu YY, Lu CC, Su YF, Tsai TH, Wu CH. Osteoporosis in adult patients with atopic dermatitis: A nationwide population-based study. PLoS One. 2017 Feb 16;12(2):e0171667. doi: 10.1371/journal.pone.0171667. eCollection 2017.</citation>
    <PMID>28207767</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Megha M. Tollefson, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bone Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800004
org study id: 17-007112
nct id: NCT03800004
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the bone health in children with atopic dermatitis
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.
observational model: Cohort
time perspective: Prospective
measure: Correlate bone mineral density to normative data
time frame: 2 years
description: 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.
measure: Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score
time frame: 2 years
description: To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores
measure: Correlate bone age with serum markers
time frame: 2 years
description: To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Megha M Tollefson, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Henry Nguyen, MD
role: Study Director
affiliation: Mayo Clinic
last name: Henry Nguyen, MD
phone: 507-284-4673
email: Nguyen.Henry@mayo.edu
last name: Katrina Pierce
phone: 507-266-1078
email: Pierce.Katrina@mayo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
citation: Garg N, Silverberg JI. Association between eczema and increased fracture and bone or joint injury in adults: a US population-based study. JAMA Dermatol. 2015 Jan;151(1):33-41. doi: 10.1001/jamadermatol.2014.2098.
PMID: 25353616
citation: Haeck IM, Hamdy NA, Timmer-de Mik L, Lentjes EG, Verhaar HJ, Knol MJ, de Bruin-Weller MS, Bruijnzeel-Koomen CA. Low bone mineral density in adult patients with moderate to severe atopic dermatitis. Br J Dermatol. 2009 Dec;161(6):1248-54. doi: 10.1111/j.1365-2133.2009.09327.x. Epub 2009 Jun 4.
PMID: 19673879
citation: van Velsen SG, Knol MJ, van Eijk RL, de Vroede MA, de Wit TC, Lam MG, Haeck IM, de Bruin-Weller MS, Bruijnzeel-Koomen CA, Pasmans SG. Bone mineral density in children with moderate to severe atopic dermatitis. J Am Acad Dermatol. 2010 Nov;63(5):824-31. doi: 10.1016/j.jaad.2009.12.015. Epub 2010 Sep 17.
PMID: 20850893
citation: Wu CY, Lu YY, Lu CC, Su YF, Tsai TH, Wu CH. Osteoporosis in adult patients with atopic dermatitis: A nationwide population-based study. PLoS One. 2017 Feb 16;12(2):e0171667. doi: 10.1371/journal.pone.0171667. eCollection 2017.
PMID: 28207767
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Megha M. Tollefson, M.D.
investigator title: Principal Investigator
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema