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

NCT00364130 | Completed Results DMC

• 2 other identifiers: 07-004906R01DK073946
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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 disease.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (3)

• Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months

  We calculated the mean change in tibia trabecular volumetric BMD Z-score between baseline and 12 months, as measured by peripheral quantitative computed tomography (pQCT). The Z-score, or Standard Deviation Score, is a measure of the number of standard deviations that an individual is above or below the median value in a healthy child or adolescent of the same age, sex and race. For example, a Z-score of 0 means that an individual's result is equivalent to the 50th percentile in a healthy population. A Z-score of -1.0 means that an individual's result is equovalent to the 16th percentile in a healthy population.

  12 months

• Change in Tibia Cortical Area Z-score 12 Months

  We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.

  12 months

• Change in Spine Volumetric BMD Z-score at 12 Months

  We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months

  12 months

Secondary Outcomes (5)

• Change in Posteroanterior Lumbar Spine Areal BMD Z-score

  12 months

• Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months

  12months

• Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months

  12 months

• Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months

  12 months

• Change in QCT Tibia Trabecular Volumetric BMD at 12 Months

  12 months

Study Arms (2)

Active Low Magnitude Mechanical Stimulus

ACTIVE COMPARATOR

Active Low Magnitude Mechanical Stimulus

Device: Low magnitude mechanical stimulus

Inactive Low Magnitude mechanical Stimulus

PLACEBO COMPARATOR

Inactive, or placebo low magnitude mechanical stimulus

Device: Placebo (inactive) low magnitude mechanical stimulus

Interventions

Low magnitude mechanical stimulus DEVICE

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

Also known as: Whole body vibration

Active Low Magnitude Mechanical Stimulus

Placebo (inactive) low magnitude mechanical stimulus DEVICE

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

Inactive Low Magnitude mechanical Stimulus

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8-21 years
• Diagnosis of Crohn disease \> 6 months
• Tibia vBMD z-score \< 25th%tile for age and sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Mary Leonard, MD, MSCE
• Organization: Children's Hospital of Philadelphia

leonard@email.chop.edu

215-590-0874

Study Officials

• Babette Zemel, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: February 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 14, 2017
• Results First Posted: July 14, 2014

Record last verified: 2017-03

Locations

US (1)