Status:
COMPLETED
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Crohn Disease
Eligibility:
All Genders
8-21 years
Phase:
NA
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 d...
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...
Eligibility Criteria
Inclusion
- Age 8-21 years
- Diagnosis of Crohn disease \> 6 months
- Tibia vBMD z-score \< 25th%tile for age and sex
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00364130
Start Date
February 1 2007
End Date
August 1 2012
Last Update
April 14 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104