Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

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.

Conditions

• Bone Mineral Density
• Bone Strength

Interventions

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.

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Gabrielle's Angel Foundation

  collaborator OTHER

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Kirsten K Ness, PT, Ph.D · St. Jude Children's Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2013-03-31

Completion

2013-03-31

Countries

• United States

Study Locations