Bone Health in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Bone Health in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800004
• Other study ID #: 17-007112
• Status: Recruiting
• Start date: July 30, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Henry Nguyen, MD
• Phone: 507-284-4673
• Email: Nguyen.Henry[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines the bone health in children with atopic dermatitis

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Pediatric Dermatology Research Alliance

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate bone mineral density to normative data	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 years
Primary	Correlate bone age with the Eczema area and severity index and the Scoring atopic dermatitis score	To correlate bone mineral density with eczema severity using Eczema area and severity index (EASI) and Scoring atopic dermatitis (SCORAD) scores	2 years
Primary	Correlate bone age with serum markers	To determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers	2 years