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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Leonard, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00364130
First received: August 14, 2006
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Crohn Disease
Device: Low magnitude mechanical stimulus
Device: Placebo (inactive) low magnitude mechanical stimulus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Change in Tibia Cortical Area Z-score 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.

  • Change in Spine Volumetric BMD Z-score at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months


Secondary Outcome Measures:
  • Change in Posteroanterior Lumbar Spine Areal BMD Z-score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA

  • Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months [ Time Frame: 12months ] [ Designated as safety issue: No ]
    We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months

  • Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA

  • Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months

  • Change in QCT Tibia Trabecular Volumetric BMD at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)


Enrollment: 138
Study Start Date: February 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Low Magnitude Mechanical Stimulus
Active Low Magnitude Mechanical Stimulus
Device: Low magnitude mechanical stimulus
10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
Other Name: Whole body vibration
Placebo Comparator: Inactive Low Magnitude mechanical Stimulus
Inactive, or placebo 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
Other Name: Placebo (inactive) low magnitude mechanical stimulus

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

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364130

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Mary B Leonard, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Mary Leonard, Principal Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00364130     History of Changes
Other Study ID Numbers: 07-004906, R01DK073946
Study First Received: August 14, 2006
Results First Received: June 12, 2014
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 18, 2014