Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

NCT01010230 | Completed Results

• 3 other identifiers: VIBER21HD059292Gabrielle's Angel Fdn
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Mineral Density; Bone Strength

Keywords

Childhood cancer survivors

Outcome Measures

Primary Outcomes (7)

• Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups

  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.

  Baseline and 12 months after start of intervention

• Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups

  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.

  Baseline and 12 months after start of intervention/

• Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups

  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.

  Baseline and 12 months after the intervention begins

• Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups

  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.

  Baseline and 12 months after the intervention begins

• Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups

  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.

  Baseline and 12 months after the intervention begins

• Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups

  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.

  Baseline and 12 months after the intervention begins

• Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups

  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.

  Baseline and 12 months after the intervention begins

Secondary Outcomes (6)

• 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

• Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups

  Baseline and 12 months after the intervention begins

• Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups

  Baseline and 12 months after the intervention begins

• 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

• Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups

  Baseline and 12 months after the intervention begins

Study Arms (2)

LMHF mechanical stimulation placebo device

PLACEBO COMPARATOR

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.

Device: LMHF mechanical stimulation placebo device

LMHF mechanical stimulation

ACTIVE COMPARATOR

Low magnitude, high frequency mechanical stimulation device ("vibrating") platform

Device: LMHF mechanical stimulation active device

Interventions

LMHF mechanical stimulation active device 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.

Also known as: Bone mineral density

LMHF mechanical stimulation

LMHF mechanical stimulation placebo device 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.

LMHF mechanical stimulation placebo device

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Gabrielle's Angel Foundation: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Mogil 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 DERIVED

Related Links

• St. Jude Children's Research Hospital

Limitations and Caveats

Dropout was higher than expected leading to small numbers for analysis. It was estimated that 30 persons were needed in each arm to detect a 5.5% difference in change in bone outcomes between the active device and placebo device arms of the study.

Results Point of Contact

• Title: Kirsten K. Ness, PT, PhD
• Organization: St. Jude Children's Research Hospital

kiri.ness@stjude.org

866-278-5833

Study Officials

• Kirsten K Ness, PT, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 9, 2009
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 4, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (1)