Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Bone Mineral Density Clinical Trial

Official title:

Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010230
• Other study ID #: VIBE
• Secondary ID: R21HD059292Gabri
• Status: Completed
• Phase: N/A
• First received: November 6, 2009
• Last updated: May 27, 2014
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Mineral Density
• Bone Strength

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gabrielle's Angel Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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/	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.	Baseline and 12 months after the intervention begins	No
Secondary	Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.	Baseline and 12 months after the intervention begins	No
Secondary	Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.	Baseline and 12 months after the intervention begins	No
Secondary	Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups	Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.	Baseline and 12 months after the intervention begins	No
Secondary	Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups	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.	Baseline and 12 months after the intervention begins	No
Secondary	Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups	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.	Baseline and 12 months after the intervention begins	No

External Links

•   St. Jude Children's Research Hospital