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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Device: Sham, wearing belt; Device: Wearable vibration belt

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Wearable belt; Device will be worn but not turned on for 30 minutes.	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.
Experimental: Wearable vibration belt (30); Device will be worn and turned on for 30 minute treatment.	Device: Wearable vibration belt; The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 30 minutes after completing the 30-minute treatment session

Collaborators and Investigators

• Sponsor: Theranova, L.L.C.
• Collaborators: University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): April 17, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: CRD-09-1105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes