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

• Sponsor: Theranova, L.L.C. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03688282
• Collaborator: University of Nebraska (Other)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia	Device: Wearable vibration belt; Device: Sham, wearing belt	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
• Actual Study Start Date: Jul 11, 2018
• Actual Primary Completion Date: Nov 29, 2018
• Actual Study Completion Date: Apr 17, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Percent Change in Blood-based Biomarker of Bone Loss [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

• Theranova, L.L.C.
• University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Apr 17, 2019

More Information

Publications

None provided.

• Responsible Party: Theranova, L.L.C.
• ClinicalTrials.gov Identifier: NCT03688282
• Other Study ID Numbers: CRD-09-1105
• First Posted: Sep 28, 2018
• Last Update Posted: Apr 27, 2021
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Bone Diseases, Metabolic

Study Results

Participant Flow

Arm/Group Title	Sham & 30 Minute Treatment
Arm/Group Description	Visit 1: Device will be worn but not turned on. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips. Visit 2: Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Period Title: Sham Treatment for 30 Minutes
STARTED	18
COMPLETED	17
NOT COMPLETED	1
Period Title: Sham Treatment for 30 Minutes
STARTED	17
COMPLETED	17
NOT COMPLETED	0
Period Title: Sham Treatment for 30 Minutes
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sham & 30 Minute Treatment
Arm/Group Description	Visit 1: Device will be worn but not turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips. Visit 2: Device will be worn and turned on for 30 minute treatment. Wearable vibration belt: The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Overall Participants	18
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	18 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.41 (4.77)
Sex: Female, Male (Count of Participants)
Female	18 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	18 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5.6%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	16 88.9%
More than one race	0 0%
Unknown or Not Reported	1 5.6%
Region of Enrollment (Count of Participants)
United States	18 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects that completed both treatment sessions

Arm/Group Title	Sham Treatment Session	Active Treatment Session
Arm/Group Description	Device will be worn but not turned on (does not deliver the active treatment) for 30 minute treatment session.	Device will be worn and turned on (delivers the active treatment) for 30 minute treatment session.
Measure Participants	17	17
Mean (Standard Deviation) [Percent change]	8.8 (7.6)	-5.4 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Treatment Session, Active Treatment Session
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Study duration (2 weeks)
Adverse Event Reporting Description	Standard definitions for serious adverse event and adverse event were used.
Arm/Group Title	Sham Treatment Session		Active Treatment Session
Arm/Group Description	Device will be worn but not turned on (does not deliver active treatment therapy) for the 30 minute treatment session.		Device will be worn and turned on (delivers active treatment therapy) for the 30 minute treatment session.
All Cause Mortality
	Sham Treatment Session		Active Treatment Session
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Serious Adverse Events
	Sham Treatment Session		Active Treatment Session
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Sham Treatment Session		Active Treatment Session
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.