Crohn DiseaseNCT00364130
Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
A study testing Low magnitude mechanical stimulus in people with Crohn Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Low magnitude mechanical stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-21 years
- Diagnosis of Crohn disease > 6 months
- Tibia vBMD z-score < 25th%tile for age and sex
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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 disease (CD) have numerous risk factors for impaired bone accumulation, including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and inflammation. We reported that children with CD had significant deficits in trabecular bone mineral density (BMD), cortical dimensions, and muscle mass; bone deficits were strongly associated with muscle deficits. No trials of therapies that build bone or prevent bone breakdown have been conducted in chronic pediatric inflammatory diseases. The capacity to increase bone mass and dimensions in response to mechanical loading is greatest during growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical stimuli (LMMS) enhances bone mass and quality. This 12-month double blind, placebo controlled randomized trial will evaluate daily 10-minute treatments with LMMS in 160 children with CD. Trabecular BMD, cortical dimensions, and muscle area will be measured by quantitative computed tomography (QCT). The LMMS device monitors adherence; these data will be transmitted by modem to the psychologist who will work closely with subjects to optimize adherence. All subjects will be provided with calcium and vitamin D supplements. The primary aims are to determine if treatment with LMMS results in increased trabecular BMD in the lower leg and spine and increased cortical dimensions in the lower leg in children with CD, compared with placebo controls.
- Conditions
- Crohn Disease
- Being tested
- Low magnitude mechanical stimulus, Placebo (inactive) low magnitude mechanical stimulus
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low magnitude mechanical stimulusDevice
Also called Whole body vibration
10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
Placebo (inactive) low magnitude mechanical stimulusDevice
10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
| Study group | Role | What they receive |
|---|---|---|
| Active Low Magnitude Mechanical Stimulus | Active comparator | Active Low Magnitude Mechanical Stimulus Receives: Device: Low magnitude mechanical stimulus |
| Inactive Low Magnitude mechanical Stimulus | Placebo comparator | Inactive, or placebo low magnitude mechanical stimulus Receives: Device: Placebo (inactive) low magnitude mechanical stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12 months
Secondary outcomes (5)
Change in Posteroanterior Lumbar Spine Areal BMD Z-score
We calculated the mean change in posterior anterior lumbar spine areal BMD Z-score between baseline and 12 months as measured by DXA
Measured: 12 months
Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months
We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months
Measured: 12months
Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months
We calculated the mean change in femoral neck areal bmd Z-score between baseline and 12 months as measured by DXA
Measured: 12 months
Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months
We calculated the mean change in whole body bone mineral content Z-score, as measured by DXA, between baseline and 12 months
Measured: 12 months
Change in QCT Tibia Trabecular Volumetric BMD at 12 Months
We calculated the mean change in tibia trabecular volumetric BMDbetween baseline and 12 months as measured by (QCT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startFeb 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babette Zemel, Children's Hospital of Philadelphia
- Investigators
- Babette Zemel, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364130
- Sponsor's protocol ID
- 07-004906
- Other IDs
- R01DK073946
- Status last verified
- Mar 2017
- First submitted
- 14 Aug 2006
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health in Pediatric Crohn's Disease: A Low Magnitude Mechanical Stimulus Trial
- ClinicalTrials.gov ID
- NCT00364130
- Acronym / sponsor ID
- 07-004906
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 disease (CD) have numerous risk factors for impaired bone accumulation, including poor growth, delayed puberty, malnutrition, glucocorticoid therapy and inflammation. We reported that children with CD had significant deficits in trabecular bone mineral density (BMD), cortical dimensions, and muscle mass; bone deficits were strongly associated with muscle deficits. No trials of therapies that build bone or prevent bone breakdown have been conducted in chronic pediatric inflammatory diseases. The capacity to increase bone mass and dimensions in response to mechanical loading is greatest during growth. Recent studies demonstrate that brief daily exposure to low magnitude mechanical stimuli (LMMS) enhances bone mass and quality. This 12-month double blind, placebo controlled randomized trial will evaluate daily 10-minute treatments with LMMS in 160 children with CD. Trabecular BMD, cortical dimensions, and muscle area will be measured by quantitative computed tomography (QCT). The LMMS device monitors adherence; these data will be transmitted by modem to the psychologist who will work closely with subjects to optimize adherence. All subjects will be provided with calcium and vitamin D supplements. The primary aims are to determine if treatment with LMMS results in increased trabecular BMD in the lower leg and spine and increased cortical dimensions in the lower leg in children with CD, compared with placebo controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Low Magnitude Mechanical Stimulus | Active comparator | Device: Low magnitude mechanical stimulusActive Low Magnitude Mechanical Stimulus |
| Inactive Low Magnitude mechanical Stimulus | Placebo comparator | Device: Placebo (inactive) low magnitude mechanical stimulusInactive, or placebo low magnitude mechanical stimulus |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 8-21 years
- Diagnosis of Crohn disease > 6 months
- Tibia vBMD z-score < 25th%tile for age and sex
Key exclusion criteria (8 listed)
- Pregnancy
- Weight > 250 lb
- Medical illness (unrelated to Crohn)
- Cognitive/developmental disorder
- Do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low magnitude mechanical stimulusAlso: Whole body vibration10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device | Device | Active Low Magnitude Mechanical Stimulus |
| Placebo (inactive) low magnitude mechanical stimulus10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device | Device | Inactive Low Magnitude mechanical Stimulus |
Primary outcome
Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months
Time frame: 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.
Change in Tibia Cortical Area Z-score 12 Months
Time frame: 12 months
We calculated the mean change in tibia cortical area Z-score, as measured by pQCT, between baseline and 12 months.
Change in Spine Volumetric BMD Z-score at 12 Months
Time frame: 12 months
We calculated the mean change in spine volumetric BMD Z-score, as measured by QCT, between baseline and 12 months
5 secondary outcomes
Change in Posteroanterior Lumbar Spine Areal BMD Z-score
Time frame: 12 months
Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months
Time frame: 12months
Change in Femoral Neck Areal BMD Z-score Between Baseline and 12 Months
Time frame: 12 months
Change in Whole Body Bone Mineral Content Z-score Between Baseline and 12 Months
Time frame: 12 months
Change in QCT Tibia Trabecular Volumetric BMD at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babette Zemel, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low magnitude mechanical stimulus in people with Crohn Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tibia Trabecular Volumetric Bone Mineral Density (BMD) Z-score at 12 Months (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.