Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women - Abstract
Osteopenia is a highly common skeletal condition with accelerated loss of bone mass that leads to osteoporosis.
Characterized by below normal bone mineral density (BMD), osteopenia affects 43 million Americans. If BMD
loss is not mitigated, patients become osteoporotic and are at increased risk of bone fractures, particularly of the
hip and spine. Such fractures decrease independent living, shorten life and increase morbidity. Clinical guidelines
for treating osteopenia include both dietary modifications and high impact exercise. While diet and exercise are
highly effective in maintaining BMD, compliance is low. The alternative is prescribed bisphosphonates, which
effectively inhibit bone resorption. However, serious adverse events with prolonged use limit their use to patients
with osteoporotic levels of BMD, when their antifracture benefits considerably outweigh their potential for harm.
Our scientific premise is that delivering mechanical stimulation to the hips and spine via a wearable vibration
device can serve as a surrogate for exercise and thus, an effective non-drug intervention for osteopenia. Whole
body vibration, which is administered by standing on a vibrating platform, has demonstrated significant
improvement in BMD in some cases. However, with substantial attenuation of vibration as it passes through the
body, a high and unsafe vibration magnitude is required to elicit an improvement in hip and spine BMD in older
individuals. TheraNova has developed Mimetix, a novel wearable vibration device designed to provide controlled,
safe and therapeutic mechanical stimulation localized to the hip and spine in order to mitigate bone mass loss
and fracture risk. In our clinical Phase I studies, we successfully demonstrated that Mimetix provides: (1) Delivery
of consistent mechanical stimulation localized to the hips and spine, (2) Effective mitigation of bone resorption
(observed via bone turnover markers (BTMs)) using safe magnitudes of vibration and (3) Enhanced potential for
patient compliance based on ease-of-use and comfort. The goal of this proposal is to validate the efficacy of
Mimetix treatment on improving bone resistance to fracture (bone strength) and BMD. In Specific Aim 1, we will
conduct a 6-week study with 20 postmenopausal patients to verify that the Mimetix device can be tuned to apply
a consistent acceleration dose to each patient. During both in-clinic and at-home use, accelerations will be
monitored via body worn accelerometers to validate personalized device calibration for delivery of consistent
levels of vibrational acceleration that are both therapeutic and safe (a) across different patients; (b) over an
extended time period; and (c) during at-home daily activities. In Specific Aim 2, we will conduct an 18-month,
prospective, single-blinded, at-home study to validate the efficacy of mechanical stimulation via the Mimetix
device compared to a sham device in 110 postmenopausal, osteopenic patients. Efficacy will be evaluated based
on (a) hip bone strength, (b) hip and spine BMD and (c) BTMs indicative of both bone formation and resorption.
Once completed, the results from these studies support regulatory approval and commercialization, allowing
Mimetix to meet the large, unmet clinical need for a simple, non-invasive, effective treatment for osteopenia.
