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

Not Recruiting

Trial ID: NCT00364130

Age - 8 Years-21 Years Condition - Pediatric Gastroenterology Gender - All Accepting Healthy Volunteers - No

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.

Official Title

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

Stanford Investigator(s)

Mary Leonard

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

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Intervention(s):

device: Low magnitude mechanical stimulus

device: Placebo (inactive) low magnitude mechanical stimulus

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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