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Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors


N/A
7 Years
17 Years
Not Enrolling
Both
Bone Mineral Density, Bone Strength

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Trial Information

Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors


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.


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
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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The outcome measures for this study are bone mineral content (BMC), bone mineral density (BMD), and bone strength that will be measured at baseline and following the 12 month intervention.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Kirsten K Ness, PT, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

VIBE

NCT ID:

NCT01010230

Start Date:

April 2010

Completion Date:

March 2013

Related Keywords:

  • Bone Mineral Density
  • Bone Strength
  • Childhood cancer survivors

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794