On January 18, 2024, the FDA cleared a novel new device for osteopenia treatment. This is a vibrating belt (wearable device) that transmits low-amplitude, high-frequency (20 to 40 Hz) vibration to the spine and hips. This belt is called Osteoboost. Osteoboost previously received a breakthrough designation from the FDA in Dec 2020. This FDA clearance has already generated a lot of commentaries regarding the single RCT results. In this episode, we will review the results critically and explain why there is a difference in “per protocol” RCT results and “intend to treat” RCT results. Is Osteoboost a game changer? Listen in and find out.
Dr. Chapa’s Clinical Pearls.