N/A
Completed N=138
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
Crohn Disease
Source: ClinicalTrials.gov NCT00364130 ↗
Enrolled (actual)
138
Serious AEs
9.4%
Results posted
Jul 2014
Primary outcomePrimary: Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months — 0.15; 0.23 Z-score — p=0.38
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.
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 |
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
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. Informational only — not medical advice.