Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Completed · Not applicable · Has a placebo group

Conditions studied: Bone Mineral Density, Bone Strength

In brief

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.

Key facts

Study ID

NCT01010230

Run by

St. Jude Children's Research Hospital

People needed

81

Starts

2010-05-01

Expected to finish

2013-03-01

Last updated by the study team

2014-06-04

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Receiving pharmacologic interventions other than Calcium and Vitamin D supplements for reduced Bone Mineral density (e.g. bisphosphonates)
• Pregnant female
• Individuals with metal implants that prevent BMD analysis by Dual X-ray Absorptiometry (DXA) or Quantitative Computed Tomography (QTC)
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent.
• Spinal deformity requiring bracing
• Chronic oral glucocorticoid therapy
• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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