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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688282
• Other study ID #: CRD-09-1105
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: April 17, 2019

Study information

• Verified date: November 2020
• Source: Theranova, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 17, 2019
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Theranova, L.L.C.	University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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