Bone Health in Patients With Atopic Dermatitis

NCT03800004 | Completed

• 1 other identifier: 17-007112
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the bone health in children with atopic dermatitis

Conditions

Atopic Dermatitis; Eczema

Keywords

Bone Health

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Pediatric Dermatology Research Alliance: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55906, United States

Location

Related 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.

  PMID: 25353616 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Megha M Tollefson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Henry Nguyen, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 10, 2019
• Study Start: July 30, 2018
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)