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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364130
• Other study ID #: 07-004906
• Secondary ID: R01DK073946
• Status: Completed
• Phase: N/A
• First received: August 14, 2006
• Last updated: August 20, 2014
• Start date: February 2007
• Est. completion date: August 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Device:
• Low magnitude mechanical stimulus
10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
• Placebo (inactive) low magnitude mechanical stimulus
10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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