A Study to Evaluate Bone Health and Contributing Factors in Children with Atopic Dermatitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-007112
NCT ID: NCT03800004
Sponsor Protocol Number: 17-007112
About this study
The goal of this study is to objectively evaluate bone health and contributing factors in children with Atopic Dermatitis (AD).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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, methotrexate, cyclosporine, and oral tacrolimus. However, medications that are used for atopic dermatitis treatment are allowed.
- Pregnant or breast feeding females
- Inability to cooperate with blood draw
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Megha Tollefson, M.D. |
Closed for enrollment |
|
More information
Publications
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The aim of this study was to investigate osteoporosis risk in atopic dermatitis (AD) patients. This study included patients in the Taiwan National Health Insurance Research dataset. The population-based study included all patients aged 20-49 years who had been diagnosed with AD during 1996-2010. In total, 35,229 age and gender-matched patients without AD in a 1:1 ratio were randomly selected as the non-AD group. Cox proportional-hazards regression and Kaplan-Meier analyses were used to measure the hazard ratios and the cumulative incidences of osteoporosis, respectively. During the follow-up period, 360(1.02%) AD patients and 127(0.36%) non-AD patients developed osteoporosis. The overall incidence of osteoporosis was4.72-fold greater in the AD patients compared to the non-AD patients (1.82 vs. 0.24 per 1,000 person-years, respectively) after adjusting for potential confounding factors. Osteoporosis risk factors included female gender, age, advanced Charlson Comorbidity Index, depression and use of corticosteroids. The dataset analysis showed that AD was significantly associated with subsequent risk of osteoporosis.
Read More on PubMed
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Adults with eczema have multiple risk factors for accidental injury. However, little is known about the risk of injury in adult patients with eczema.
Read More on PubMed
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Low bone mineral density (BMD) has been reported in 30.4% of adult patients with atopic dermatitis (AD).
Read More on PubMed
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Atopic dermatitis (AD) is a chronic inflammatory skin disease commonly treated with topical corticosteroids. The inflammatory nature of this disorder and the use of topical corticosteroids represent potential risk factors for bone loss.
Read More on PubMed