Bone Mineral Density, Bone Strength
Conditions
Keywords
Childhood cancer survivors
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.
Detailed 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.
Interventions
DEVICELMHF 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.
DEVICELMHF 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Gabrielle's Angel Foundation
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups | Baseline and 12 months after start of intervention | 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. |
| Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups | Baseline and 12 months after start of intervention/ | 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. |
| Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. |
| Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. |
| 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 | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. |
| Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups | Baseline and 12 months after the intervention begins | 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. |
| 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 | Biological markers of bone formation and cytokines collected at baseline and 12 months were evaluated to see if there was change over time. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 26 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | LMHF Mechanical Stimulation | Placebo Device | Total |
|---|---|---|---|
| Age, Continuous | 13.4 years STANDARD_DEVIATION 2.7 | 13.5 years STANDARD_DEVIATION 2.8 | 13.5 years STANDARD_DEVIATION 2.8 |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 26 |
| serious Total, serious adverse events | 0 / 22 | 1 / 26 |
Outcome results
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Percent Change in Cortical Bone Per Length Compared Between the Intervention and Placebo Groups | -1.86 % change in mg/cm^4 | Standard Deviation 6.77 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.7395% CI: [-2.02, 3.33]ANOVA
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.
Time frame: Baseline and 12 months after start of intervention/
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Percent Change in Lumbar Spine Bone Mineral Content (BMC) Compared Between Intervention and Placebo Groups | 2.54 % change in grams/cm | Standard Deviation 21.09 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.8595% CI: [-6.93, 9.25]ANOVA
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Percent Change in Lumbar Spine Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | 5.01 % change in g/cm^2 | Standard Deviation 10.29 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.9795% CI: [-4.24, 4.05]ANOVA
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Percent Change in Lumbar Spine Volumetric Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | 5.30 % change in mg/cc | Standard Deviation 11.06 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.9195% CI: [-4.05, 4.68]ANOVA
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups | 3.00 % change in mg/cc | Standard Deviation 4.69 |
| Placebo Device | Percent Change in Tibial Cortical Bone Compared Between the Intervention and Placebo Groups | 1.77 % change in mg/cc | Standard Deviation 4.9 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.495% CI: [-0.69, 3.11]ANOVA
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.
Time frame: Baseline and 12 months after start of intervention
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Percent Change in Total Bone Mineral Content (BMC) Per Height Compared Between Intervention and Placebo Groups | 3.96 % change in grams/cm | Standard Deviation 11.31 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.6995% CI: [-5.59, 3.11]ANOVA
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | 7.08 % change in g/cm^2 | Standard Deviation 10.2 |
| Placebo Device | Percent Change in Total Bone Mineral Density (BMD) Compared Between Intervention and Placebo Groups | 4.88 % change in g/cm^2 | Standard Deviation 6.9 |
Comparison: The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.p-value: 0.1295% CI: [0.43, 5.95]ANOVA
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Mean Change in Alkaline Phosphatase (ALP)-Skeletal (Bone Specific) Compared Between the Intervention and Placebo Groups | -0.31 log of µg/L | Standard Deviation 0.3 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.1795% CI: [0, 0.26]t-test, 2 sided
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Mean Change in Aminoterminal Propeptide of Type I Procollagen (PINP) Compared Between the Intervention and Placebo Groups | -0.29 log of µg/L | Standard Deviation 0.34 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.1895% CI: [0, 0.35]t-test, 2 sided
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Mean Change in Bone Turnover Ratio (RANKL/OPG) Compared Between the Intervention and Placebo Groups | -0.14 ratio of RANKL/OPG | Standard Deviation 0.5 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.0695% CI: [0.09, 0.46]t-test, 2 sided
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 0.3 |
| Placebo Device | Mean Change in Carboxyterminal Telopeptide of Type I Collagen (ITCP) Compared Between the Intervention and Placebo Groups | -0.19 log of µg/l | Standard Deviation 0.31 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.3895% CI: [-0.04, 0.2]t-test, 2 sided
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | 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 |
| Placebo Device | Mean Change in Collagen Cross Linked N-Telepeptide (NTx) Compared Between the Intervention and Placebo Groups | -0.28 log of 10 nmol BCE/L | Standard Deviation 0.43 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.8895% CI: [-0.22, 0.18]t-test, 2 sided
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.
Time frame: Baseline and 12 months after the intervention begins
Population: This was an intent to treat analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LMHF Mechanical Stimulation | Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups | -0.06 log of ng/mL | Standard Deviation 0.3 |
| Placebo Device | Mean Change in Osteocalcin (OC) Compared Between the Intervention and Placebo Groups | -0.27 log of ng/mL | Standard Deviation 0.41 |
Comparison: Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.p-value: 0.0895% CI: [0.06, 0.34]t-test, 2 sided