Bone Mass Accrual in Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Bone Mass Accrual in Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162445
• Other study ID #: 2009P002422
• Status: Completed
• Phase: N/A
• First received: May 12, 2017
• Last updated: May 19, 2017
• Start date: January 11, 2010
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a observational study to investigate the degree to which bone mineral density is impaired in boys with autism compared with typically developing controls.

Description:

Studies have shown that bone cortical thickness is decreased in children with autism and other developmental disabilities. However it is not known whether bone mineral density (BMD) of these children is lower; neither is it known whether there is any correlation between BMD and the child's diet. The overall goal of this study is to improve the long term health of children and adolescents with autism spectrum disorder; more specifically the investigators aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with autism and to explore specific additional risk factors. In addition, the aim is to investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD) and to explore specific contributing risk factors including nutritional analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Boys 8-17 years chronological age

• BMI between the 3rd and 97th percentiles

• Meets DSM-IV criteria for Autism Spectrum Disorder (ASD group)

• Scores <15 on the Social Communication Questionnaire (control group)

Exclusion Criteria:

• Use of medications directly affecting bone metabolism including estrogen/ progesterone preparations and glucocorticoids except local application of glucocorticoid

• Use of anticonvulsants which affect bone density including diphenylhydantoin, phenobarbital, topiramate carbamazepine and valproic acid and also use of lithium

• Children with diseases known to affect bone mineral density including Crohn's disease, celiac, thyroid and renal

• Children who will not tolerate lying still for 30 seconds

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Bone Diseases
• Bone Diseases, Developmental
• Child Development Disorders, Pervasive
• Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	using dual energy x-ray absorptiometry (DXA) (Hologic Discovery A, Software Version: APEX 4.0.2, Bedford, MA USA) at the total hip, femoral neck, lumbar spine (L1-4), whole body and whole body less head bone mineral density.	Bone mineral density will be assessed within one month of enrolling in the study.