Back to resultsWearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Primary Purpose
Osteopenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable vibration belt
Sham, wearing belt
Sponsored by
About this trial
This is an interventional basic science trial for Osteopenia
Eligibility Criteria
Inclusion Criteria:
- Female
- 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.
- Hip circumference is greater than 42 inches
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham Wearable belt
Wearable vibration belt (30)
Arm Description
Device will be worn but not turned on for 30 minutes.
Device will be worn and turned on for 30 minute treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03688282
First Posted
September 19, 2018
Last Updated
April 1, 2021
Sponsor
Theranova, L.L.C.
Collaborators
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT03688282
Brief Title
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Official Title
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
April 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranova, L.L.C.
Collaborators
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Wearable belt
Arm Type
Sham Comparator
Arm Description
Device will be worn but not turned on for 30 minutes.
Arm Title
Wearable vibration belt (30)
Arm Type
Experimental
Arm Description
Device will be worn and turned on for 30 minute treatment.
Intervention Type
Device
Intervention Name(s)
Wearable vibration belt
Intervention Description
The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Intervention Type
Device
Intervention Name(s)
Sham, wearing belt
Intervention Description
The device is worn, for a specified time. It will not be turned on during this period. It is only sham.
Primary Outcome Measure Information:
Title
Percent Change in Blood-based Biomarker of Bone Loss
Description
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.
Time Frame
Baseline and 30 minutes after completing the 30-minute treatment session
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female
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.
Hip circumference is greater than 42 inches
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
We'll reach out to this number within 24 hrs