Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors
Condition: Bone Mineral Density; Bone Strength
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): LMHF mechanical stimulation active device; LMHF mechanical stimulation placebo device
Intervention type(s): Device; Device
Intervention description(s): 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.; 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 intervention name(s): Bone mineral density
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Childhood cancer survivors