Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial - NCT00364130-19104 (Clinical Trial 147678)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy147678.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Philadelphia |
|
State:
|
|
PA |
| Zip Code: |
|
19104 |
| Conditions: |
|
Crohn Disease |
| Purpose: |
|
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.
|
| Study summary: |
|
Skeletal growth is characterized by increases in the size of the hard outer layer of bone
(cortical bone), and the density of the inner layer of bone (trabecular or "spongy" bone).
Children with Crohn disease (CD) have numerous risk factors for impaired bone accumulation,
including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and
inflammation. We reported that children with CD had significant deficits in trabecular bone
mineral density (BMD), cortical dimensions, and muscle mass; bone deficits were strongly
associated with muscle deficits. No trials of therapies that build bone or prevent bone
breakdown have been conducted in chronic pediatric inflammatory diseases. The capacity to
increase bone mass and dimensions in response to mechanical loading is greatest during
growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical
stimuli (LMMS) enhances bone mass and quality. This 12-month double blind, placebo
controlled randomized trial will evaluate daily 10-minute treatments with LMMS in 160
children with CD. Trabecular BMD, cortical dimensions, and muscle area will be measured by
quantitative computed tomography (QCT). The LMMS device monitors adherence; these data will
be transmitted by modem to the psychologist who will work closely with subjects to optimize
adherence. All subjects will be provided with calcium and vitamin D supplements. The
primary aims are to determine if treatment with LMMS results in increased trabecular BMD in
the lower leg and spine and increased cortical dimensions in the lower leg in children with
CD, compared with placebo controls. Secondary analyses will examine (1) the effect of LMMS
on the functional muscle-bone unit, (2) the impact of pubertal stage, physical activity, and
disease characteristics (e.g., steroid treatment) on the response to LMMS, (3) the
sensitivity of dual energy x-ray absorptiometry (DXA) to detect treatment effects, and (4)
changes in bone and muscle over 12 months off therapy following completion of the trial in
subjects randomized to active devices. |
| Criteria: |
|
Inclusion Criteria:
- Age 8-18 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 is available at: |
|
The Children's Hospital of Philadelphia
Philadelphia, PA 19104
United States
Primary Contact:
Krista M Howard, BS
Email: howardk@email.chop.edu
Phone: 215-590-1248 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 15, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|