OMNISENSE 7000S/8000S

Clinical Summary #2

Multisite Bone Ultrasound Measurement on
a North American Female Reference Population  

W. M. Drake, C. F Njeh, M. McClung, H. K. Genant, C. Rosen,
N. Watts, D. L. Kendler

This study describes the method of data collection for the North American Female Reference Database of the Omnisense device.

Study Design
This study measured the speed of sound (SOS) at four skeletal sites with the Sunlight Omnisense™7000S. For the study, 545 healthy Caucasian women aged 20-90 were recruited from five centers across North America. Data was collected and analyzed to establish the Omnisense reference curve and peak speed of sound (SOS) for each site.

Subjects
Subjects for the study were required to meet the following criteria:

• No history of osteoporotic fracture or any condition affecting bone metabolism.
• No exposure for more than a year within the preceding three years to a medication affecting bone.

Results
Results demonstrated that peak SOS occurs around the age of 40. The maximal rate of decline of SOS was seen in the decade following menopause at the radius, tibia, metatarsal, and phalanx respectively. Reproducibility between successive measurements indicates high precision.

When comparing Omnisense SOS to bone density assessment devices such as DXA, it is noted that SOS measurements peak at a later age. This demonstrates that Omnisense SOS measurements reflect additional bone properties, including elasticity, cortical thickness, and micro-architecture.

Conclusion
Sunlight Omnisense™ bone measurements clearly established the age-dependent pattern of bone loss for adult North American Caucasian females. Omnisense-measured prevalence of osteoporosis in the female population between the ages of 60-90 is about 35%--the same as vertebral DXA. Based on this prevalence, Omnisense measurements meet WHO criteria for osteoporosis.

Osteoporosis
Bone Densitometry
''For better prevention, detection, diagnosis,
and treatments of Osteoporosis''
278 S. Lincoln St., Minster, OH 45865
Phone: 1-888-999-4774
Fax: 1-419-628-4005
Email: info@bonedensitometry.com

"As president, I have committed my company to providing medical facilities with "state-of-the-art" bone densitometry equipment to help them do a better job with preventing, testing for, screening for, detecting, diagnosing, and treating Osteoporosis which ravage so many women and men. Our diagnostic equipment will speed up the prevention, detection, diagnosis, and treatment of Osteoporosis and osteoporotic bone disorders in men and women. The key to preventing Osteoporosis in women and men is early detection, diagnosis, and treatment. This means measuring, testing, screening, detecting, and diagnosing low bone mass in women and men early in their lifetimes so that effective treatment can stop the Osteoporosis dead in its tracks." Together, we can help protect families from this terrible disease.

Sincerely,
Mark Piening

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