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

NCT00364130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2017-04-14

Study results available
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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.

Conditions

  • Crohn Disease

Interventions

DEVICE

Low magnitude mechanical stimulus

10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device

DEVICE

Placebo (inactive) low magnitude mechanical stimulus

10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device

Sponsors & Collaborators

Principal Investigators

  • Babette Zemel, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364130 on ClinicalTrials.gov