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Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010230
First Posted: November 9, 2009
Last Update Posted: June 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention
Bone Mineral Density Bone Strength Device: LMHF mechanical stimulation active device Device: LMHF mechanical stimulation placebo device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ]
    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.

  • 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/ ]
    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.

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

  • 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 ]
    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.

  • 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 ]
    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.

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

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


Secondary Outcome Measures:
  • 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 ]
    Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.

  • Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups [ Time Frame: Baseline and 12 months after the intervention begins ]
    Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.

  • 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 ]
    Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.

  • 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 ]
    Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.

  • 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 ]
    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.

  • 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 ]

    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.



Enrollment: 81
Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: LMHF mechanical stimulation 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.
Device: LMHF mechanical stimulation placebo 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.
Active Comparator: LMHF mechanical stimulation
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
Device: LMHF mechanical stimulation active 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.
Other Name: Bone mineral density

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously treated for childhood cancer at SJCRH
  2. Greater than or equal to 5 years from childhood cancer diagnosis
  3. Age and gender matched lumbar or whole body BMD z-score of <or equal -1.0
  4. Not undergoing active treatment for cancer
  5. ≥ 7 and <18 years of age
  6. Able to stand for 10 minutes (May hold on to a support while standing)
  7. Able to tolerate Calcium and Vitamin D supplements

Exclusion Criteria:

  1. Receiving pharmacologic interventions other than Calcium and Vitamin D supplements for reduced Bone Mineral density (e.g. bisphosphonates)
  2. Pregnant female
  3. Individuals with metal implants that prevent BMD analysis by Dual X-ray Absorptiometry (DXA) or Quantitative Computed Tomography (QTC)
  4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent.
  5. Spinal deformity requiring bracing
  6. Chronic oral glucocorticoid therapy
  7. Diagnosis of hereditary retinoblastoma (bilateral disease, familial, or positive test), Li-Fraumeni syndrome (positive testing for p53 mutation), Gorlin syndrome/Basil Cell Nevus syndrome, Bloom syndrome, Fanconi anemia, Ataxia telangiectasia or xeroderma pigmentosa
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010230


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gabrielle's Angel Foundation
Investigators
Principal Investigator: Kirsten K Ness, PT, Ph.D St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01010230     History of Changes
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
Last Verified: April 2014

Keywords provided by St. Jude Children's Research Hospital:
Childhood cancer survivors


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