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

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Crohn Disease

Treatments: Device: Low magnitude mechanical stimulus; Device: Placebo (inactive) low magnitude mechanical stimulus

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00364130

07-004906

R01DK073946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 138 patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups, including a placebo group

Active Low Magnitude Mechanical Stimulus

Active Comparator group

Description:

Active Low Magnitude Mechanical Stimulus

Treatment:

Device: Low magnitude mechanical stimulus

Inactive Low Magnitude mechanical Stimulus

Placebo Comparator group

Description:

Inactive, or placebo low magnitude mechanical stimulus

Treatment:

Device: Placebo (inactive) low magnitude mechanical stimulus