Clinical trial NCT00364130: Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Official title: Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-08-15
Enrollment: 138
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months
timeFrame: 12 months
measure: Change in Tibia Cortical Area Z-score 12 Months
timeFrame: 12 months
measure: Change in Spine Volumetric BMD Z-score at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in Posteroanterior Lumbar Spine Areal BMD Z-score
timeFrame: 12 months
measure: Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months
timeFrame: 12months
measure: Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months
timeFrame: 12 months
measure: Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months
timeFrame: 12 months
measure: Change in QCT Tibia Trabecular Volumetric BMD at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Babette Zemel, MD
role: PRINCIPAL_INVESTIGATOR
References: