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Exclusive Reference Database
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Omnisense 7000S includes male and female reference databases,
making it the only bone sonometer in the United States to offer an approved male reference database
collected in North America. Each database includes reference curves
for each of the recommended
skeletal sites; the distal 1/3 radius, the proximal third
phalanx, and the fifth metatarsal.
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The Omnisense North American male and female reference databases
were collected in various geographic regions in the United States and Canada. All subjects were
between the ages of 20 - 90 and met strict eligibility criteria. Each skeletal site was measured
in accordance with Omnisense's strict measurement methodology.
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WHO Compliant |
The Omnisense reference curve meets the WHO criteria for osteoporosis,
defined as the proportion of subjects with measurement results of 2.5 standard deviations
or more below the norm for healthy young adults. When measured by Omnisense, the prevalance of osteoporosis
among post-menopausal women is similar to that identified by the WHO Study Group that defined the criteria for osteoporosis*: approximately
35% in the 60-90 North American female population group.
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Proven |
Much discussion has been devoted to the appropriate sample size needed to establish a statistically significant reference database.
Sunlight researchers have taken the initiative to gather measurement data from over 6000 subjects measured at 14 different centers from around the world.
These subjects were not pre-selected nor were there any special qualification criteria applied to them. Both the system curve and the new curve were then compared
by their mean and standard deviation, and no statistical differences were found to exist, reinforcing the validity of the Omnisense reference curve.
*"Assessment of Fracture Risk and its Application to Screening for Postmenopausal Osteoporosis," Report of a WHO Study Group,
WHO Technical Report Series #843, World Health Organization, Geneva 1994
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