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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK073946 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Low Magnitude Mechanical Stimulus | Active Comparator | Active Low Magnitude Mechanical Stimulus |
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| Inactive Low Magnitude mechanical Stimulus | Placebo Comparator | Inactive, or placebo low magnitude mechanical stimulus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low magnitude mechanical stimulus | Device | 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Change in Total Hip Areal BMD Z-score Between Baseline and 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babette Zemel, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Patients between the ages of 8-21 years with a diagnosis of Crohn disease for at least 6 months were eligible for a screening visit. Patients meeting the entry criteria (pQCT trabecular volumetric BMD z-score below the 25th percentile)were randomly allocated 1:1 to an active LMMS device or a placebo device.
The recruitment period began May 17, 2007 and ended June 25, 2010. Participants were recruited from the Center for Inflammatory Bowel Disease at CHOP and through referrals from physicians outside CHOP. The study was also advertised on the Crohn's and Colitis Foundation Website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Active Low Magnitude Mechanical Stimulus Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device |
| FG001 | Pacebo | Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period |
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| Post Intervention Follow-up Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Active Low Magnitude Mechanical Stimulus Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device |
| BG001 | Pacebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat. | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
Adverse event data were collected at 6 months, 1 year and 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Active Low Magnitude Mechanical Stimulus Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization for infection | Infections and infestations | Systematic Assessment | hospitalization for various infectsion: pneumonia, viral infection, cellulitis, clostridium difficile infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Leonard, MD, MSCE | Children's Hospital of Philadelphia | 215-590-0874 | leonard@email.chop.edu |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo (inactive) low magnitude mechanical stimulus | Device | 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device |
|
We calculated the mean change in total hip bone mineral density z-score, as measured by DXA, between baseline and 12 months |
| 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 | 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 | 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) | 12 months |
| Withdrawal by Subject |
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| NOT COMPLETED |
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Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Active Low Magnitude Mechanical Stimulus
Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device
| OG001 | Pacebo | Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device |
|
|
|
| Primary | 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. | The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat. | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
|
|
|
| Primary | 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 | The number was determined by the number of participants with measures at both baseline and 12 month time points. The analysis was intention to treat. | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Z-score | 12months |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Z-score | 12 months |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | cm^3 | 12 months |
|
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|
|
| 7 |
| 69 |
| 10 |
| 69 |
| EG001 | Pacebo | Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device | 6 | 69 | 10 | 69 |
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| hospitalization for for appendectomy | Surgical and medical procedures | Systematic Assessment |
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| Hospitalization for migraine headache | Nervous system disorders | Systematic Assessment |
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| hospitalization for small bowel overgrowth | Gastrointestinal disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| stool changes | Gastrointestinal disorders | Non-systematic Assessment | increased frequency, urgency, increased loose stools/diarrhea |
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| lower extremity pain | Musculoskeletal and connective tissue disorders | knee, leg, ankle or foot pain |
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| D007410 | Intestinal Diseases |