Evaluation of the Spry Belt for Improving Bone Quality

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.