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Completed

NCT Number: NCT03162445

Bone Mass Accrual in Children With Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Bone Diseases Bone Diseases, Developmental Child Development Disorders, Pervasive Mental Disorders Musculoskeletal Diseases Neurodevelopmental Disorders

Age range

8 year–17 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bone Mineral Density

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 22, 2017
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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