Clinical trial · Interventional
Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Mineral Density | — | UNRESOLVED | — |
| Bone Strength | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LMHF mechanical stimulation active device | Device | — | UNRESOLVED |
| LMHF mechanical stimulation placebo device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- LMHF mechanical stimulation placebo device
- description
- 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.
- interventionNames
- Device: LMHF mechanical stimulation placebo device
- type
- ACTIVE_COMPARATOR
- label
- LMHF mechanical stimulation
- description
- Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
- interventionNames
- Device: LMHF mechanical stimulation active device
Primary outcomes (7)
- measure
- Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously treated for childhood cancer at SJCRH 2. Greater than or equal to 5 years from childhood cancer diagnosis 3. Age and gender matched lumbar or whole body BMD z-score of \<or equal -1.0 4. Not undergoing active treatment for cancer 5. ≥ 7 and \<18 years of age 6. Able to stand for 10 minutes (May hold on to a support while standing) 7. Able to tolerate Calcium and Vitamin D supplements Exclusion Criteria: 1. Receiving pharmacologic interventions other than Calcium and Vitamin D supplements for reduced Bone Mineral density (e.g. bisphosphonates) 2. Pregnant female 3. Individuals with metal implants that prevent BMD analysis by Dual X-ray Absorptiometry (DXA) or Quantitative Computed Tomography (QTC) 4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent. 5. Spinal deformity requiring bracing 6. Chronic oral glucocorticoid therapy 7. 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
References
Publications (1)
- DERIVEDMogil RJ, Kaste SC, Ferry RJ Jr, Hudson MM, Mulrooney DA, Howell CR, Partin RE, Srivastava DK, Robison LL, Ness KK. Effect of Low-Magnitude, High-Frequency Mechanical Stimulation on BMD Among Young Childhood Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Jul 1;2(7):908-14. doi: 10.1001/jamaoncol.2015.6557. PMID 26967465