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Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model

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ClinicalTrials.gov Identifier: NCT01148121
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
This study may provide information that may serve as the foundation for a larger research study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the Down syndrome patient population.

Condition or disease Intervention/treatment Phase
Down Syndrome Other: Skeletal Status Assessment of a Down Syndrome Population Not Applicable

Detailed Description:

Osteoporosis is responsible for more than 1.5 million fractures and $14 billion in medical care costs annually (U.S Dept of Health and Human Services data, 2006). Down syndrome is an independent risk factor for osteopenia/osteoporosis. Increases in life expectancy as well as costly morbidity following fracture are reasons for further investigation of osteoporosis and prevention in this population. Etiology for low bone density is presently unknown in this population but may be related to unique genes on chromosome 21 which alter the biochemistry of bone metabolism or change the gonadal, thyroid and parathyroid function to alter bone formation and/or resorption. There are no published data on the measurement of bone turnover markers in the Down syndrome population; therefore we will measure and accrue this information and compare to our Ts65Dn data, as described later in this protocol.

This pilot study will serve as the foundation for a larger translational research grant which will address multiple issues regarding the pathogenesis, diagnosis and treatment of osteoporosis in the Down syndrome patient population and the Down syndrome mouse model (Ts65Dn). The data has the potential to improve our fundamental understanding of osteoporosis pathogenesis and treatment in the Down syndrome patient with potential applications to treatment in the general population.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model
Study Start Date : June 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Skeletal Status Assessment of a Down Syndrome Population
    The investigators hypothesize that the bone deficits seen in Down Syndrome patients are similar to the phenotype seen in the down syndrome mouse model (Ts65Dn).The bone turnover markers, CBC, and DXA scan results will be used to assess the skeletal status of the down syndrome patients. This data will form the basis to establish the Ts65Dn as a reasonable proxy for pathogenesis and treatment in humans.


Primary Outcome Measures :
  1. Ts65DN pathogenesis proxy [ Time Frame: 1 year ]
    The bone turnover markers, Complete Blood Count (CBC) and the Duel Energy X-ray (DXA) scan results will be used to assess the skeletal status of the Down syndrome patients. This data will form the basis to establish the Ts65Dn as a reasonable proxy for pathogenesis and treatment in humans.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females of all races and ethnicities
  • Age 18 or older and current clinical diagnosis of Down Syndrome

Exclusion Criteria:

  • No legally authorized representative (if applicable) willing to provide informed consent. Any condition the investigator determines will put the subject at risk by participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148121


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Kent D McKelvey, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01148121     History of Changes
Other Study ID Numbers: 113810
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn