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

Theranova, L.L.C.1 site in 1 country18 target enrollmentJuly 11, 2018

ConditionsOsteopenia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteopenia
Sponsor: Theranova, L.L.C.
Enrollment: 18
Locations: 1
Primary Endpoint: Percent Change in Blood-based Biomarker of Bone Loss
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 11, 2018

End Date

April 17, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Theranova, L.L.C.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Last menstrual period at least one year prior and not more than eight years prior.
•19 years of age and older.
•BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
•Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).
•Able to understand spoken and written English.
•Capable and willing to follow all study-related procedures.

Exclusion Criteria

•BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
•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).
•Weight \> 300 lbs.
•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.
•Active cancer or cancer treatment.
•Any change in exercise in the past 3 months.
•Fractures or major surgery within the past 6 months.
•Medical Implants (excluding dental implants).
•Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.
•Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.

Outcomes

Primary Outcomes

Percent Change in Blood-based Biomarker of Bone Loss

Time Frame: 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.