NCT03688282

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DEVICE	Wearable vibration belt	The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
DEVICE	Sham, wearing belt	The device is worn, for a specified time. It will not be turned on during this period. It is only sham.

Timeline

• Start date: 2018-07-11
• Primary completion: 2018-11-29
• Completion: 2019-04-17
• First posted: 2018-09-28
• Last updated: 2021-04-27
• Results posted: 2021-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study