Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors
| Status: | Archived |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | March 2013 |
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.
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
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.
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