Crohn Disease Clinical Trial
Official title:
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Verified date | August 2014 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this 12-month double blind, placebo controlled randomized trial is to evaluate the effects of daily treatments with low magnitude mechanical stimuli on bone in 160 children with Crohn disease.
Status | Completed |
Enrollment | 138 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 21 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 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 | No |
Primary | Change in Tibia Cortical Area Z-score 12 Months | We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months. | 12 months | No |
Primary | Change in Spine Volumetric BMD Z-score at 12 Months | We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months | 12 months | No |
Secondary | Change in Posteroanterior Lumbar Spine Areal BMD Z-score | 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 | No |
Secondary | Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months | We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months | 12months | No |
Secondary | Change in Femoral Neck Areal BMD Z-score Between Baseline and 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 | No |
Secondary | Change in Whole Body Bone Mineral Content Z-score Between Baseline and 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 | No |
Secondary | Change in QCT Tibia Trabecular Volumetric BMD at 12 Months | We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT) | 12 months | No |
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