Bone Mass Accrual in Children With Autism Spectrum Disorder

May 19, 2017 updated by: Ann Neumeyer, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

49

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community advertisements (ASD and control) matched for age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Typically developing controls
Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development
Autism spectrum disorder
Boys between ages 7 and 14 years old at study onset without medications or diseases impairing bone development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Bone mineral density will be assessed within one month of enrolling in the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Ann M Neumeyer, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 12, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P002422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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