Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

TheraNova

Status: Completed

Conditions: Osteopenia

Treatments: Device: Wearable vibration belt; Device: Sham, wearing belt

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03688282

CRD-09-1105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Sham Wearable belt

Sham Comparator group

Description:

Device will be worn but not turned on for 30 minutes.

Treatment:

Device: Sham, wearing belt

Wearable vibration belt (30)

Experimental group

Description:

Device will be worn and turned on for 30 minute treatment.

Treatment:

Device: Wearable vibration belt