Clinical trial NCT03688282: Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Official title: Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: Theranova, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: University of Nebraska
First posted: 2018-09-28
Enrollment: 18
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Blood-based Biomarker of Bone Loss
timeFrame: Baseline and 30 minutes after completing the 30-minute treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
References: