Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Trial ID or NCT#
NCT00364130
Status
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
Eligibility Criteria
Ages Eligible for Study: 8 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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
Investigator(s)
Mary Leonard
View on ClinicalTrials.gov