Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Not Applicable

Completed

Conditions: Bone Mineral Density
Bone Strength

Interventions: Device: LMHF mechanical stimulation active device
Device: LMHF mechanical stimulation placebo device

Registration Number: NCT01010230

Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMHF mechanical stimulation	LMHF mechanical stimulation active device	Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation placebo device	LMHF mechanical stimulation placebo device	The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.

Primary Outcome Measures

Name	Time	Method
Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups	Baseline and 12 months after start of intervention/	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.
Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups	Baseline and 12 months after start of intervention	Since this is considered a "pilot study" we did not adjust for multiple comparisons. These % changes were treated as continuous variables and analyzed using two way ANOVAs adjusting for stratification.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. BCE = Bone Collagen Equivalent.
Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups	Baseline and 12 months after the intervention begins	Biological markers evaluated are: Osteoprotegerin (OPG)/receptor activator nuclear factor kB ligand (sRANKL) index. Between-group comparisons used two-sample t-tests. Biomarkers and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. Variables were log transformed for analysis.