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Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile

Osteopenia Clinical Trial

Official title:
Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile in a 12-week, Sham-controlled Clinical Study

Clinical Trial Summary

To conduct a sham-controlled study to rigorously evaluate the effect of Spry Belt treatment on key bone turnover markers (BTMs) over a 12-week period. The investigators will calculate the percentage and absolute changes from baseline for several BTMs for both the active and sham treatment groups.

Clinical Trial Description

This will be a 12-week, randomized, controlled study with 90 subjects. At enrollment, subjects will be randomized to the Active Treatment or Sham Treatment. All subjects will receive dietary supplements (calcium and vitamin D) for the duration of the study. Subjects will be asked to self-administer daily at-home treatments with the device at least 5 times each week. The investigators will evaluate safety via adverse events reported to the research staff and via responses to a survey on potential side effects. DXA scans will be obtained at the Screening Visit and Visit 3 (Study Completion). Blood and urine will be collected at Day 0 (Visit 1), Week 6 (Visit 2), and Week 12 (Visit 3). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05457036
Study type Interventional
Source Bone Health Technologies, Inc.
Contact
Status Completed
Phase N/A
Start date September 1, 2022
Completion date December 10, 2023
View Details
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