- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00364130
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 8-21 years
- Diagnosis of Crohn disease > 6 months
- Tibia vBMD z-score < 25th%tile for age and sex
Exclusion Criteria:
- Pregnancy
- Weight > 250 lb
- Medical illness (unrelated to Crohn)
- Cognitive/developmental disorder
- Do not speak English
- > 1 primary residence
- Unwilling to commit to 2 year study
- Sibling or cousin enrolled in trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active Low Magnitude Mechanical Stimulus
|
10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
Other Names:
|
PLACEBO_COMPARATOR: Inactive Low Magnitude mechanical Stimulus
Inactive, or placebo low magnitude mechanical stimulus
|
10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months
Time Frame: 12 months
|
We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT). The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population. |
12 months
|
Change in Tibia Cortical Area Z-score 12 Months
Time Frame: 12 months
|
We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.
|
12 months
|
Change in Spine Volumetric BMD Z-score at 12 Months
Time Frame: 12 months
|
We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Posteroanterior Lumbar Spine Areal BMD Z-score
Time Frame: 12 months
|
We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA
|
12 months
|
Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months
Time Frame: 12months
|
We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months
|
12months
|
Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months
Time Frame: 12 months
|
We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA
|
12 months
|
Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months
Time Frame: 12 months
|
We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months
|
12 months
|
Change in QCT Tibia Trabecular Volumetric BMD at 12 Months
Time Frame: 12 months
|
We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Babette Zemel, MD, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-004906
- R01DK073946 (NIH)
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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