NCT00364130

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DEVICE	Low magnitude mechanical stimulus	10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
DEVICE	Placebo (inactive) low magnitude mechanical stimulus	10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device

Timeline

• Start date: 2007-02-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2006-08-15
• Last updated: 2017-04-14
• Results posted: 2014-07-14

Locations

1 site across 1 country: United States