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Trial record 1 of 1 for:    NCT01010230
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Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01010230
Recruitment Status : Completed
First Posted : November 9, 2009
Results First Posted : May 26, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gabrielle's Angel Foundation
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Bone Mineral Density
Bone Strength
Interventions Device: LMHF mechanical stimulation active device
Device: LMHF mechanical stimulation placebo device
Enrollment 81
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 32 33
Completed 22 26
Not Completed 10 7
Reason Not Completed
Withdrawal by Subject             6             5
Lost to Follow-up             4             2
Arm/Group Title LMHF Mechanical Stimulation Placebo Device Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 22 26 48
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 26 participants 48 participants
13.4  (2.7) 13.5  (2.8) 13.5  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 26 participants 48 participants
Female
10
  45.5%
12
  46.2%
22
  45.8%
Male
12
  54.5%
14
  53.8%
26
  54.2%
1.Primary Outcome
Title Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after start of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in grams/cm
2.72  (10.41) 3.96  (11.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments BMC was normalized for height and adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-5.59 to 3.11
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after start of intervention/
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in grams/cm
3.70  (21.15) 2.54  (21.09)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments The threshold for significance was established a priori at alpha=0.05
Method ANOVA
Comments BMC was normalized for height and adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
-6.93 to 9.25
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in g/cm^2
7.08  (10.20) 4.88  (6.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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 estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments Adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.19
Confidence Interval (2-Sided) 95%
0.43 to 5.95
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in g/cm^2
4.91  (10.34) 5.01  (10.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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 estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments Adjusted for sex and tanner stage (from general linear model).
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-4.24 to 4.05
Estimation Comments [Not Specified]
5.Primary Outcome
Title Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in mg/cc
5.64  (10.83) 5.30  (11.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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 estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments Adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-4.05 to 4.68
Estimation Comments [Not Specified]
6.Primary Outcome
Title Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in mg/cc
3.00  (4.69) 1.77  (4.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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 estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments Adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-0.69 to 3.11
Estimation Comments [Not Specified]
7.Primary Outcome
Title Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: % change in mg/cm^4
-1.19  (6.63) -1.86  (6.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments 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 estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments The threshold for significance was established a priori at alpha=0.05.
Method ANOVA
Comments Adjusted for sex and tanner stage.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-2.02 to 3.33
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups
Hide Description Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: log of µg/L
-0.11  (0.51) -0.29  (0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.18
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
0.00 to 0.35
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups
Hide Description Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: log of ng/mL
-0.06  (0.30) -0.27  (0.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.08
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
0.06 to 0.34
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups
Hide Description Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: log of µg/L
-0.18  (0.34) -0.31  (0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.17
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
0.00 to 0.26
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups
Hide Description Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: log of µg/l
-0.11  (0.30) -0.19  (0.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.38
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.04 to 0.20
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups
Hide Description 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.
Time Frame Baseline and 12 months after the intervention begins
Hide Outcome Measure Data
Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: log of 10 nmol BCE/L
-0.30  (0.56) -0.28  (0.43)
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Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.88
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.22 to 0.18
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups
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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.

Time Frame Baseline and 12 months after the intervention begins
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Hide Analysis Population Description
This was an intent to treat analysis.
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
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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.

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.

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: ratio of RANKL/OPG
0.14  (0.44) -0.14  (0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LMHF Mechanical Stimulation, Placebo Device
Comments Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The power calculation was based on the primary aim and is provided above.
Statistical Test of Hypothesis P-Value 0.06
Comments The threshold for significance was established a priori at alpha=0.05.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.09 to 0.46
Estimation Comments [Not Specified]
Time Frame Adverse events were collected from the on-study date until 12 months after the start of intervention.
Adverse Event Reporting Description 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.
 
Arm/Group Title LMHF Mechanical Stimulation Placebo Device
Hide Arm/Group Description

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.

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.

All-Cause Mortality
LMHF Mechanical Stimulation Placebo Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
LMHF Mechanical Stimulation Placebo Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      1/26 (3.85%)    
Surgical and medical procedures     
Appendectomy *  0/22 (0.00%)  0 1/26 (3.85%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LMHF Mechanical Stimulation Placebo Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/26 (0.00%)    
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kirsten K. Ness, PT, PhD
Organization: St. Jude Children's Research Hospital
Phone: 866-278-5833
EMail: kiri.ness@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01010230    
Other Study ID Numbers: VIBE
R21HD059292 ( U.S. NIH Grant/Contract )
Gabrielle's Angel Fdn ( Other Identifier: Gabrielle's Angel Foundation )
First Submitted: November 6, 2009
First Posted: November 9, 2009
Results First Submitted: April 25, 2014
Results First Posted: May 26, 2014
Last Update Posted: June 4, 2014