Trial Outcomes & Findings for Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors (NCT NCT01010230)
NCT ID: NCT01010230
Last Updated: 2014-06-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Baseline and 12 months after start of intervention
Results posted on
2014-06-04
Participant Flow
81 participants enrolled 05/2010-10/2012. Each was: treated for childhood cancer, 5+ years from diagnosis, lumbar or whole body BMD z-scores of \< -1.0, not currently being treated for cancer, 7-17 years, able to stand 10 min., tolerated calcium and vitamin-D supplements. Those with untreated endocrine disorders and pregnant females were excluded.
Fifteen participants were deemed ineligible after baseline testing, 11 because their bone density z-scores were \> -1.0, one because they were on an oral steroid, one was older than the maximum age limit and two had unstable endocrine status. Two additional participants consented, but withdrew prior to baseline testing.
Participant milestones
| Measure |
LMHF Mechanical Stimulation
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
LMHF Mechanical Stimulation
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
Baseline Characteristics
Vibration Intervention For Bone Enhancement In Childhood Cancer Survivors
Baseline characteristics by cohort
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.4 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
13.5 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 months after start of interventionPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups
|
2.72 % change in grams/cm
Standard Deviation 10.41
|
3.96 % change in grams/cm
Standard Deviation 11.31
|
PRIMARY outcome
Timeframe: Baseline and 12 months after start of intervention/Population: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups
|
3.70 % change in grams/cm
Standard Deviation 21.15
|
2.54 % change in grams/cm
Standard Deviation 21.09
|
PRIMARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
|
7.08 % change in g/cm^2
Standard Deviation 10.20
|
4.88 % change in g/cm^2
Standard Deviation 6.90
|
PRIMARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
|
4.91 % change in g/cm^2
Standard Deviation 10.34
|
5.01 % change in g/cm^2
Standard Deviation 10.29
|
PRIMARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups
|
5.64 % change in mg/cc
Standard Deviation 10.83
|
5.30 % change in mg/cc
Standard Deviation 11.06
|
PRIMARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups
|
3.00 % change in mg/cc
Standard Deviation 4.69
|
1.77 % change in mg/cc
Standard Deviation 4.90
|
PRIMARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups
|
-1.19 % change in mg/cm^4
Standard Deviation 6.63
|
-1.86 % change in mg/cm^4
Standard Deviation 6.77
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups
|
-0.11 log of µg/L
Standard Deviation 0.51
|
-0.29 log of µg/L
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups
|
-0.06 log of ng/mL
Standard Deviation 0.30
|
-0.27 log of ng/mL
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups
|
-0.18 log of µg/L
Standard Deviation 0.34
|
-0.31 log of µg/L
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups
|
-0.11 log of µg/l
Standard Deviation 0.30
|
-0.19 log of µg/l
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups
|
-0.30 log of 10 nmol BCE/L
Standard Deviation 0.56
|
-0.28 log of 10 nmol BCE/L
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Baseline and 12 months after the intervention beginsPopulation: This was an intent to treat analysis.
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.
Outcome measures
| Measure |
LMHF Mechanical Stimulation
n=22 Participants
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 Participants
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups
|
0.14 ratio of RANKL/OPG
Standard Deviation 0.44
|
-0.14 ratio of RANKL/OPG
Standard Deviation 0.50
|
Adverse Events
LMHF Mechanical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Device
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LMHF Mechanical Stimulation
n=22 participants at risk
Low magnitude, high frequency mechanical stimulation device ("vibrating") platform
LMHF mechanical stimulation active device: Participants were 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 hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention.
|
Placebo Device
n=26 participants at risk
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.
Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm.
|
|---|---|---|
|
Surgical and medical procedures
Appendectomy
|
0.00%
0/22 • Adverse events were collected from the on-study date until 12 months after the start of intervention.
Adverse events were reported in real time. The SJCRH IRB requires that study PI's report any unanticipated events involving risk to subjects or others during the conduct of the study. Appropriate action is discussed and the PI is notified to implement the decided action plan.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from the on-study date until 12 months after the start of intervention.
Adverse events were reported in real time. The SJCRH IRB requires that study PI's report any unanticipated events involving risk to subjects or others during the conduct of the study. Appropriate action is discussed and the PI is notified to implement the decided action plan.
|
Other adverse events
Adverse event data not reported
Additional Information
Kirsten K. Ness, PT, PhD
St. Jude Children's Research Hospital
Phone: 866-278-5833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place