Down SyndromeNCT01148121
Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model
A study testing Skeletal Status Assessment of a Down Syndrome Population in people with Down Syndrome, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Skeletal Status Assessment of a Down Syndrome Population
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females of all races and ethnicities
- Age 18 or older and current clinical diagnosis of Down Syndrome
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Skeletal Status Assessment of a Down Syndrome Population
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal Status Assessment of a Down Syndrome PopulationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ts65DN pathogenesis proxy
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kent D McKelvey, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148121
- Sponsor's protocol ID
- 113810
- Status last verified
- Dec 2016
- First submitted
- 18 Jun 2010
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model
- ClinicalTrials.gov ID
- NCT01148121
- Acronym / sponsor ID
- 113810
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and Females of all races and ethnicities
- Age 18 or older and current clinical diagnosis of Down Syndrome
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletal Status Assessment of a Down Syndrome PopulationThe 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent D McKelvey, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletal Status Assessment of a Down Syndrome Population in people with Down Syndrome, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ts65DN pathogenesis proxy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.