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Evaluation of the Spry Belt for Improving Bone Quality

NCT03986203 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-04-06

No results posted yet for this study

Summary

The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt. The Spry Belt is intended to deliver energy to the user's skeleton to reduce the progression of age-related decrease in bone quality in postmenopausal women. Half of the participants will receive the active treatment, while the other half will receive the sham/placebo treatment.

Conditions

  • Osteopenia

Interventions

DEVICE

Spry Belt

The Spry Belt delivers energy to the user that may help prevent bone loss. Participants will wear the device for 30 minutes a day, 5 days a week for one year. The active and sham devices are identical except for the specific energy that is delivered to the user.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Nebraska

    collaborator OTHER

  • Theranova, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Laura Bilek, PT, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2022-05-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03986203 on ClinicalTrials.gov