Osteopenia
Conditions
Brief summary
The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to whole body vibration and is plausibly more effective at preventing bone loss in postmenopausal women than vibration platforms in the home setting.
Detailed description
The goal of this study is to demonstrate that postmenopausal women will tolerate our device, have high rates of compliance with the study protocol, receive consistently therapeutic levels of vibration and see significant effects on bone turnover based on plasma markers of bone anabolism and catabolism. The anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the WVD.
Interventions
DEVICEWearable vibration belt
The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
DEVICESham, wearing belt
The device is worn, for a specified time. It will not be turned on during this period. It is only sham.
Sponsors
University of Nebraska
Theranova, L.L.C.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Female 2. Last menstrual period at least one year prior and not more than eight years prior. 3. 19 years of age and older. 4. BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA. 5. Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes). 6. Able to understand spoken and written English. 7. Capable and willing to follow all study-related procedures.
Exclusion criteria
1. BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA. 2. A 10-year probability of hip fracture of \> 3% or major fracture of \> 20% based on results of DXA using the FRAX tool (see attached). 3. Weight \> 300 lbs. 4. Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months. 5. Active cancer or cancer treatment. 6. Any change in exercise in the past 3 months. 7. Fractures or major surgery within the past 6 months. 8. Medical Implants (excluding dental implants). 9. Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis. 10. Any bleeding disorder or treatment with a blood thinning medication within the last 2 years. 11. Hip circumference is greater than 42 inches
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Blood-based Biomarker of Bone Loss | Baseline and 30 minutes after completing the 30-minute treatment session | Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham & 30 Minute Treatment Visit 1:
Device will be worn but not turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Visit 2:
Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Sham & 30 Minute Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 54.41 years STANDARD_DEVIATION 4.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Percent Change in Blood-based Biomarker of Bone Loss
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.
Time frame: Baseline and 30 minutes after completing the 30-minute treatment session
Population: All subjects that completed both treatment sessions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham Treatment Session | Percent Change in Blood-based Biomarker of Bone Loss | 8.8 Percent change | Standard Deviation 7.6 |
| Active Treatment Session | Percent Change in Blood-based Biomarker of Bone Loss | -5.4 Percent change | Standard Deviation 8.8 |
p-value: <0.001t-test, 2 sided