NCT03986203

Evaluation of the Spry Belt for Improving Bone Quality

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Women lose a significant amount of bone after menopause and are at high risk of breaking bones. Bone cells have been shown to be responsive to different forms of applied energy, which can be used to reduce the progression of age-related declines in bone properties. The purpose of this research study is to evaluate the safety and effectiveness of the Spry Belt when used regularly over one year. The Spry Belt, a medical device that is worn around the hips like a belt, provides energy to the user's skeleton with the goal of improving bone quality in postmenopausal women with osteopenia, or low bone mass. In this randomized, controlled study, all participants will receive the Spry Belt for at-home use over the 12 month study. Participants will be randomized (1:1) to the active or sham/placebo treatment group and give a Spry Belt that is pre-programmed to deliver the corresponding therapy. Participants will self-administer treatment sessions at least 5 times per week for 12 months. The effectiveness of the Spry Belt treatment will be assessed via CT and DXA scans of the user's bones to evaluate changes in bone density and strength over the study duration.

Conditions

• Osteopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-13
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2019-06-14
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study