Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Low Magnitude Mechanical Stimulus

Group Type ACTIVE_COMPARATOR

Low magnitude mechanical stimulus

Intervention Type DEVICE

10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device

Inactive Low Magnitude mechanical Stimulus

Inactive, or placebo low magnitude mechanical stimulus

Group Type PLACEBO_COMPARATOR

Placebo (inactive) low magnitude mechanical stimulus

Intervention Type DEVICE

10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device

Interventions

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Low magnitude mechanical stimulus

10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device

Intervention Type DEVICE

Placebo (inactive) low magnitude mechanical stimulus

10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device

Intervention Type DEVICE

Other Intervention Names

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Whole body vibration

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No