Clinical trial NCT03800004: Bone Health in Patients With Atopic Dermatitis
Official title: Bone Health in Patients With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Eczema
Keywords: Bone Health
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pediatric Dermatology Research Alliance
First posted: 2019-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist

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.

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

Primary outcomes:
measure: Correlate bone mineral density to normative data
timeFrame: 2 years
measure: Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score
timeFrame: 2 years
measure: Correlate bone age with serum markers
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Megha M Tollefson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Henry Nguyen, MD
role: STUDY_DIRECTOR
References:
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: 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: 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: 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.