Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

This study has been completed.
Sponsor:
Collaborators:
Gabrielle's Angel Foundation
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01010230
First received: November 6, 2009
Last updated: May 27, 2014
Last verified: April 2014
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Bone Mineral Density
Bone Strength
Interventions: Device: LMHF mechanical stimulation active device
Device: LMHF mechanical stimulation placebo device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    LMHF Mechanical Stimulation     Placebo Device  
STARTED     32     33  
COMPLETED     22     26  
NOT COMPLETED     10     7  
Withdrawal by Subject                 6                 5  
Lost to Follow-up                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
    LMHF Mechanical Stimulation     Placebo Device     Total  
Number of Participants  
[units: participants]
  22     26     48  
Age  
[units: years]
Mean ± Standard Deviation
  13.4  ± 2.7     13.5  ± 2.8     13.5  ± 2.8  
Gender  
[units: participants]
     
Female     10     12     22  
Male     12     14     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after start of intervention ]

2.  Primary:   Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after start of intervention/ ]

3.  Primary:   Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

4.  Primary:   Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

5.  Primary:   Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

6.  Primary:   Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

7.  Primary:   Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

8.  Secondary:   Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

9.  Secondary:   Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

10.  Secondary:   Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

11.  Secondary:   Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

12.  Secondary:   Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]

13.  Secondary:   Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups   [ Time Frame: Baseline and 12 months after the intervention begins ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kirsten K. Ness, PT, PhD
Organization: St. Jude Children's Research Hospital
phone: 866-278-5833
e-mail: kiri.ness@stjude.org


No publications provided


Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01010230     History of Changes
Other Study ID Numbers: VIBE, R21HD059292, Gabrielle's Angel Fdn
Study First Received: November 6, 2009
Results First Received: April 25, 2014
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board