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

NCT03688282 | Completed Results FDA Device

• 1 other identifier: CRD-09-1105
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sham Wearable belt

SHAM COMPARATOR

Device will be worn but not turned on for 30 minutes.

Device: Sham, wearing belt

Wearable vibration belt (30)

EXPERIMENTAL

Device will be worn and turned on for 30 minute treatment.

Device: Wearable vibration belt

Interventions

Wearable vibration belt DEVICE

The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.

Wearable vibration belt (30)

Sham, wearing belt DEVICE

The device is worn, for a specified time. It will not be turned on during this period. It is only sham.

Sham Wearable belt

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Last menstrual period at least one year prior and not more than eight years prior.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Theranova, L.L.C.: lead
• University of Nebraska: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Vice President of Research and Development
• Organization: TheraNova

clinicalstudy@theranova.com

415-926-8616

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 28, 2018
• Study Start: July 11, 2018
• Primary Completion: November 29, 2018
• Study Completion: April 17, 2019
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)