Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
Phase: NA
Conditions: Osteopenia
Sponsor: Theranova, L.L.C.

April 17, 2019 
 
 
 
 
 
Theranova, LLC 
 
CLINICAL STUDY PROTOCOL – TNV-0514-WVD; CRD-09-1105 
 
NCT03688282 
 
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women – Aim 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

April 17, 2019 
Protocol Summary 
 
Title 
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women– Aim 2 
Sponsor 
Theranova, LLC 
Device 
Wearable Vibration Device (WVD) 
Background 
and Rationale 
An emerging alternative to pharmacological interventions for osteoporosis is whole-body 
vibration (WBV). The wearable vibration device (WVD) 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-based force feedback will provide a superior alternative to WBV platforms and is 
plausibly more effective at preventing bone loss in postmenopausal women than vibration 
platforms in the home setting. 
Objectives. 
To demonstrate that postmenopausal women will: 
1. Tolerate our device; 
2. Receive consistently therapeutic levels of vibration; and  
3. See changes in bone turnover. 
Indications for 
Use/Patient 
Population 
The device is to be worn by women who are postmenopausal to deliver vibration to the hips 
and spine to prevent bone loss. Subjects will be instructed to wear the device 30 minutes while 
walking or standing. 
Trial Design 
Single center prospective, non-randomized, unblinded, Non-Significant Risk (NSR) trial. 
Study 
Population 
Postmenopausal women 
Number of 
Subjects 
Up to 24  
Number of 
Sites 
1 

April 17, 2019 
Study Flow Outline Revised 
 
Recruitment  
and Screening 
Baseline Visit  
(Office Visit #1) 
Intervention 
Assessment  
(Office Visit #2) 
Process Payment 
Contact Interested Subjects 
Determine Eligibility 
Schedule Baseline Visit 
Enrollment Consent 
Fit Device 
Pre-Activity Blood Draw 
30 Min Self-Selected Activity 
 (WVD Motor Off) 
Wait 30 Minutes 
Patient Questionnaires 
Post Activity Blood Draw 
Fit Device 
Pre-Activity Blood Draw 
30 Min Self-Selected Activity 
 (WVD Motor On) 
Wait 30 Minutes 
Patient Questionnaires 
Post Activity Blood Draw 
  
 
Internal Control 
Acute assessment of bone 
marker with no vibration 
stimulus. 
 
Treatment 
Acute assessment of 
bone marker with 30 
minute vibration. 
 
 
Study 
Procedures 
Screening Period (Ongoing) 
Potential subjects will answer screening questions via phone to determine eligibility. Women 
who qualify based on screening criteria will be scheduled for a baseline visit at the University of 
Nebraska Medical Center.  Subjects with low or normal bone mass may be enrolled in the 
study. 
 
Study Period (1-2 weeks) 
The two week protocol consists of subjects: 1) visiting the clinic for a Wearable Vibration Device 
(WVD) pack fitting, wearing the device (motor off) for 30 minutes while standing or walking, and 
completing a pre-post activity blood draw,  2) visiting the clinic at the end of week one to 
measure acceleration, wear the device (motor on) for 30 minutes while standing or walking, and 
complete a pre-post activity blood draw. 
Safety & Safety 
Monitoring 
It is the responsibility of the investigator to report when an adverse event has occurred.  
Adverse event information will be collected throughout the study. Adverse Events (both 
expected and unexpected) will be recorded and reported appropriately. 
Inclusion 
Criteria 
1. Female 
2. Last menstrual period at least one year and not more than six years. 
3. 19 years of age and older. 
4. BMD T-score at or above -2.5 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. 

April 17, 2019 
Exclusion 
Criteria 
1. BMD T-score at or below -2.49 at the total hip and L1-L4 spine skeletal sites as measured 
by DXA. 
2. A 10-year probability of hip fracture > 3% or major fracture or > 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 6 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 Calcium or Vitamin D supplementation within the last 3 months. 
7. Any change in exercise in the past 6 months. 
8. Fractures or major surgery within the past 6 months. 
9. Medical Implants (excluding dental implants). 
10. Diagnosed with Paget’s disease, heart disease, uncontrolled hypertension, renal disease, 
chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe 
osteoarthritis. 
11. Any bleeding disorder or treatment with a blood thinning medication within the last 2 years. 
 
Statistical 
Analysis 
This study is observational, is not statistically powered and no formal statistical analyses are 
planned. Data will be listed by subject; treatment number, and subject tolerability during 
treatment.