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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD059292 | U.S. NIH Grant/Contract | View source | |
| Gabrielle's Angel Fdn | Other Identifier | Gabrielle's Angel Foundation |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Gabrielle's Angel Foundation | OTHER |
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Treatment for childhood cancer interferes with normal bone maturation such that maximal peak bone mass may never be attained by some survivors of childhood cancer. In childhood cancer survivors, a randomized trial evaluating the effectiveness of vitamin D and calcium supplementation among ALL survivors is currently underway; however, few other interventions have been offered for this at risk population. Recent evidence demonstrates that low magnitude; high frequency mechanical stimulation can improve bone quantity and quality, perhaps providing an alternative or adjunct to pharmacologic intervention in populations where additional medications are either contraindicated or not acceptable to the individuals at risk. This application proposes a prospective double blind randomized clinical trial of low magnitude, high frequency mechanical (LMHF) stimulation for childhood cancer survivors whose bone mineral density is one or more standard deviations below the mean for their age and gender.
This study is a two arm parallel allocation of participants to either the intervention or control group will be utilized for a one year trial.
Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. Participants in the control arm will stand on a placebo device.
This study will evaluate the effects of low magnitude, high frequency stimulus on bone mineral content(BMC), bone mineral density (BMD), and bone strength in childhood cancer survivors who present with BMD values 1.0 or more standard deviations below the mean for their age and gender for the lumbar or whole body. This study will evaluate the effects of low magnitude, high frequency stimulus on markers of bone turnover in childhood cancer survivors who present with BMD values 1.0 or more standard deviations below the mean for their age and gender for the lumbar or whole body.
At baseline participants will have evaluations to determine bone mineral content and bone mineral density (Dual X-ray Absorptiometry and Qualitative Computed Tomography) and a blood sample collected to measure biomarkers of bone turnover, hormonal status and Vitamin D metabolism. Anthropometrics and tanner stage will be obtained at baseline, 3 months, 6 months, 9 and 12 months. A physical activity monitor will be worn for a 7 day period and a food frequency questionnaire will be completed. Tibial length will be measured. Participants have a blood sample collected either at home or at St. Jude Children's Research Hospital (SJCRH) every 3 months during the study to measure biomarkers of bone turnover, hormonal status and Vitamin D metabolism, anthropometrics and tanner stage, physical activity monitor and food frequency questionnaire. All measurements and evaluations required at baseline will be repeated at the completion of study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMHF mechanical stimulation placebo device | Placebo Comparator | The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. |
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| LMHF mechanical stimulation | Active Comparator | Low magnitude, high frequency mechanical stimulation device ("vibrating") platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMHF mechanical stimulation active device | Device | Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after start of intervention |
| Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after start of intervention/ |
| Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after the intervention begins |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after the intervention begins |
| Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | Baseline and 12 months after the intervention begins |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten K Ness, PT, Ph.D | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26967465 | Derived | Mogil RJ, Kaste SC, Ferry RJ Jr, Hudson MM, Mulrooney DA, Howell CR, Partin RE, Srivastava DK, Robison LL, Ness KK. Effect of Low-Magnitude, High-Frequency Mechanical Stimulation on BMD Among Young Childhood Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):908-14. doi: 10.1001/jamaoncol.2015.6557. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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Fifteen participants were deemed ineligible after baseline testing, 11 because their bone density z-scores were > -1.0, one because they were on an oral steroid, one was older than the maximum age limit and two had unstable endocrine status. Two additional participants consented, but withdrew prior to baseline testing.
81 participants enrolled 05/2010-10/2012. Each was: treated for childhood cancer, 5+ years from diagnosis, lumbar or whole body BMD z-scores of < -1.0, not currently being treated for cancer, 7-17 years, able to stand 10 min., tolerated calcium and vitamin-D supplements. Those with untreated endocrine disorders and pregnant females were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | LMHF Mechanical Stimulation | Low magnitude, high frequency mechanical stimulation device ("vibrating") platform LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention. |
| FG001 | Placebo Device | The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we will have roughly 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
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| ID | Title | Description |
|---|---|---|
| BG000 | LMHF Mechanical Stimulation | Low magnitude, high frequency mechanical stimulation device ("vibrating") platform LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention. |
| 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, Continuous | Mean |
| 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 | Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in grams/cm | Baseline and 12 months after start of intervention |
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Adverse events were collected from the on-study date until 12 months after the start of intervention.
Adverse events were reported in real time. The SJCRH IRB requires that study PI's report any unanticipated events involving risk to subjects or others during the conduct of the study. Appropriate action is discussed and the PI is notified to implement the decided action plan.
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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 | LMHF Mechanical Stimulation | Low magnitude, high frequency mechanical stimulation device ("vibrating") platform LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendectomy | Surgical and medical procedures | Non-systematic Assessment |
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Dropout was higher than expected leading to small numbers for analysis. It was estimated that 30 persons were needed in each arm to detect a 5.5% difference in change in bone outcomes between the active device and placebo device arms of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten K. Ness, PT, PhD | St. Jude Children's Research Hospital | 866-278-5833 | kiri.ness@stjude.org |
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| LMHF mechanical stimulation placebo device | Device | Participants will be randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device ("vibrating") platform for 10 minutes twice daily for one year. The study hypothesizes participants in the intervention arm intervention will demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who are randomized to the placebo intervention. |
|
| Baseline and 12 months after the intervention begins |
| Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after the intervention begins |
| Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | Baseline and 12 months after the intervention begins |
| Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups |
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. |
| Baseline and 12 months after the intervention begins |
| Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | Baseline and 12 months after the intervention begins |
| Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | Baseline and 12 months after the intervention begins |
| Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent. | Baseline and 12 months after the intervention begins |
| Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups | Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index. Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis. | Baseline and 12 months after the intervention begins |
| BG001 | Placebo Device | The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Placebo Device | The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm. |
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| Secondary | Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | log of µg/L | Baseline and 12 months after the intervention begins |
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| Primary | Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in grams/cm | Baseline and 12 months after start of intervention/ |
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| Primary | Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in g/cm^2 | Baseline and 12 months after the intervention begins |
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| Primary | Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in g/cm^2 | Baseline and 12 months after the intervention begins |
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| Primary | Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in mg/cc | Baseline and 12 months after the intervention begins |
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| Primary | Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in mg/cc | Baseline and 12 months after the intervention begins |
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| Primary | Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups | Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | % change in mg/cm^4 | Baseline and 12 months after the intervention begins |
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| Secondary | Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | log of ng/mL | Baseline and 12 months after the intervention begins |
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| Secondary | Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | log of µg/L | Baseline and 12 months after the intervention begins |
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| Secondary | Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | log of µg/l | Baseline and 12 months after the intervention begins |
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| Secondary | Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | log of 10 nmol BCE/L | Baseline and 12 months after the intervention begins |
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| Secondary | Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups | Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index. Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis. | This was an intent to treat analysis. | Posted | Mean | Standard Deviation | ratio of RANKL/OPG | Baseline and 12 months after the intervention begins |
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| 0 |
| 22 |
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| 22 |
| EG001 | Placebo Device | The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration. Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm. | 1 | 26 | 0 | 26 |
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