Bone Mass Accrual in Children With Autism Spectrum Disorder

Completed

• Conditions: Bone Diseases, Developmental; Autism Spectrum Disorder

• Registration Number: NCT03162445
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-22
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	Bone mineral density will be assessed within one month of enrolling in the study.	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.