N/A N=138 Randomized Quadruple-blind Treatment

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

Crohn Disease

Bottom Line

View on ClinicalTrials.gov: NCT00364130 ↗

Enrolled (actual)

138

Serious AEs

9.4%

Results posted

Jul 2014

Primary outcome: Primary: Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months — 0.15; 0.23 Z-score — p=0.38

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low magnitude mechanical stimulus (Device); Placebo (inactive) low magnitude mechanical stimulus (Device)
Age: Pediatric, Adult · 8+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months	0.15; 0.23	0.38
PRIMARY Change in Tibia Cortical Area Z-score 12 Months	0.17; 0.20	0.80
PRIMARY Change in Spine Volumetric BMD Z-score at 12 Months	0.22; -0.02	0.02 sig
SECONDARY Change in Posteroanterior Lumbar Spine Areal BMD Z-score	0.20; 0.09	0.27
SECONDARY Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months	0.24; 0.25	0.84
SECONDARY Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months	0.19; 0.22	0.66
SECONDARY Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months	0.20; 0.18	0.70
SECONDARY Change in QCT Tibia Trabecular Volumetric BMD at 12 Months	1.05; 1.35	0.98

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.

Eligibility Criteria

Inclusion Criteria

Age 8-21 years
Diagnosis of Crohn disease > 6 months
Tibia vBMD z-score 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00364130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.