N/A N=65 Randomized Double-blind Treatment

Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Bone Mineral Density · Bone Strength

Bottom Line

View on ClinicalTrials.gov: NCT01010230 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

May 2014

Primary outcome: Primary: Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups — 2.72; 3.96 % change in grams/cm — p=0.69

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LMHF mechanical stimulation active device (Device); LMHF mechanical stimulation placebo device (Device)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: St. Jude Children's Research Hospital
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups	2.72; 3.96	0.69
PRIMARY Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups	3.70; 2.54	0.85
PRIMARY Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	7.08; 4.88	0.12
PRIMARY Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	4.91; 5.01	0.97
PRIMARY Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups	5.64; 5.30	0.91
PRIMARY Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups	3.00; 1.77	0.40
PRIMARY Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups	-1.19; -1.86	0.73
SECONDARY Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups	-0.11; -0.29	0.18
SECONDARY Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups	-0.06; -0.27	0.08
SECONDARY Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups	-0.18; -0.31	0.17
SECONDARY Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups	-0.11; -0.19	0.38
SECONDARY Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups	-0.30; -0.28	0.88
SECONDARY Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups	0.14; -0.14	0.06

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01010230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.