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OSTEOPOROSIS IS A DISEASE OF THE BONES, WHICH LEADS TO AN INCREASED RISK OF FRACTURE. IN OSTEOPOROSIS, THE BONE MINERAL DENSITY (BMD) IS REDUCED AND THE AMOUNT AND VARIETY OF PROTEINS IN THE BONE ARE ALTERED.
The most common form of osteoporosis in wom-
INCREASED BURDEN
en after menopause is referred to as primary type
OF OSTEOPOROTIC FRACTURES WORLDWIDE
1 or postmenopausal osteoporosis. Primary type 2 osteoporosis, or senile osteoporosis, occurs after age 75 and is seen in both females and males at a ratio of 2:1. Secondary osteoporosis may arise at any age and affects men and women equally.
1990
1.66M HIP FRACTURES WORLDWIDE
2050
6.62M HIP FRACTURES WORLDWIDE
3250 800
The most important risk factors for osteoporosis are advanced age (in both men and women) and female sex. For women, estrogen deficiency following menopause is correlated with a rapid reduction in bone mineral density, while in men,
600 400 200
a decrease in testosterone levels has a comparable effect. While osteoporosis occurs in people from all ethnic groups, European or Asian ancestry predisposes to osteoporosis. Those with a
NORTH AMERICA
EUROPE
LATIN AMERICA
ASIA
Source: The Breaking Spine, International Oseoporosis Foundation
family history of fracture or osteoporosis are at an increased risk; the heritability of the fracture, as well as low bone mineral density, is relatively high, ranging from 25"% to 80"%. Those who have
(DXA). Ultrasound and quantitative computed
already had a fracture are at least twice as likely
tomography devices are also used. DXA mea-
to have another fracture, compared to someone
surement is relatively expensive, is not readily
of the same age and sex.
available everywhere, and exposes the patient to
Other factors related to osteoporosis are, for
enables screening of large populations, at a rea-
example, excessive alcohol use, vitamin D defi-
sonable cost, and without the radiation exposure
ciency, smoking, malnutrition, high dietary protein
to radiation..
radiation. The OS Bone Sonometer, by contrast,
and being underweight. Calcium, exercise and vitamin D can help to preUp to this point, the diagnosis of osteoporosis has
vent osteoporosis. Medical treatment and lifestyle
relied primarily on the dual energy X-ray device
changes can further prevent bone loss.
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DESIGNED FOR: Detection of osteoporosis
Population screening
Monitoring of osteoporosis effects
OS Bone Sonometer is based on a low-frequency
AGE DEPENDENCE OF
(~200"kHz) ultrasound. Ultrasound and propaga-
LF ULTRASOUND VELOCITY
tion speed of ultrasonic guided waves provide information on the hardness of the bone, which is defined by the a) geometry, b) density and c) stiffness of the bone.
RADIUS LF VFAS APPARENT VELOCITY (m/s) 4100 4050
The measurement is taken on the radius. Often,
4000
osteoporosis is detected only when the bone is
3950
already fractured. In contrast to the tibia or heel,
3900
developing osteoporosis will be detected earlier
3850
on the radius, due to less mechanical stress on
3800
radius.. The most common areas for an osteopo-
3750
rotic fracture, besides the radius, are the hips and
3700
thoracic vertebra.
3650
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The axial velocity of ultrasound from the OS Bone
20
30
40
50
60
70
80
90
AGE (years)
Sonometer correlates with bone mineral density (BMD) and cortical thickness. Based on clinical study data, it calculates the commonly approved Z-Score and T-Score, as defined by the World Health Organization (WHO). Z-Score, by contrast, is used to compare with othT-Score compares the bone density to the aver-
ers of the same age, ethnicity and gender. This
age bone density of a healthy person of the same
score is useful for determining whether there is
gender. It is reported as a number of standard
something unusual contributing to the bone loss.
deviations below the average. A T-score of greater
A Z-Score of less than -1.5 indicates the possibility
than -1 is considered normal. A value of -1 to -2.5
of other contributing factors, in addition to ageing,
is considered to indicate osteopenia (osteoporo-
to an osteoporotic diagnosis. These factors may
sis pre-stage). A T-score of less than -2.5 is con-
include thyroid abnormalities, malnutrition, medi-
sidered to indicate osteoporosis.
cation interactions and excessive use of tobacco.
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The OS Bone Sonometer measures ultrasound wave propagation lengthwise in the bone, featuring a sensor that has several transmitting and
ąŗEasy to install software
receiving ultrasonic heads. In comparison to most other ultrasound bone sonometers, OS"Bone
ąŗBasic user training leads to quick
Sonometer has a lower ultrasound frequency, of
patient measurement of 5"min on
about 200"kHz, as well as a different sensor head
average
geometry, and different operational logic, which helps to eliminate the effect of soft tissue. Lowfrequency ultrasound travels deeper in to the
ąŗOS Bone Sonometer gives indication on T-Scores and Z-Scores
bone tissue than higher frequency ultrasound, and, therefore, produces better measuring resolution at different bone densities.
ąŗOS Bone Sonometer delivers valuable information if patient is in osteopenia or osteoporosis risk zone
Several pulses are transmitted in sequence to ensure that the measurement is correct. The device compares the measurement result to the
ąŗOS Bone Sonometer helps in treatment planning and follow-up
available reference population group data and calculates the Z- and T-Score values, indicating if the patient is in the osteopenia or osteoporosis risk zones. A qualified doctor can now use this data, in combination with other data available about the patient for treatment planning and follow-up, and, if the doctor feels necessary, can still send the patient for the DXA.
REFERENCES
Low-frequency axial ultrasound velocity correlates with bone mineral density and cortical thickness in the radius and tibia in pre- and postmenopausal women Authors: V.Kilappa, P.Moilanen, L.Xu, P.H.F. Nicholson, J.Timonen, S.Cheng Discrimination of fractures by low-frequency axial transmission ultrasound in postmenopausal females Authors: P.Moilanen, M.Määttä, V.Kilappa, L.Xu, P.H.F. Nicholson, M.Alén, J.Timonen, T.Jämsä, S.Zheng
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ąŗ Compact in size ąŗ Mobile ąŗ Low-frequency (200"kHz) axial ultrasound velocity correlates well with bone mineral density (BMD) and cortical thickness, giving valuable information on bone strength
ąŗ Detection of cortical and cancellous bone
with patented soft tissue disturbance effect elimination
ąŗ No ionizing radiation —
measurement can be repeated when needed
ąŗ OS Bone Sonometer is cost-effective and enables large scale screening
ąŗ No lead covered treatment room needed,
or specialized nurses qualified for taking X-rays
ąŗ User interface software runs in standard Windows operating system
ąŗ No dedicated PC needed ąŗ Reliable and quick procedure
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Type:
OUD-01-C-01-01 The device meets applicable CE requirements.
Dimensions:
Sensor head: 105"x"37"x"87 mm (LxWxH) Table top unit: 78"x"37"x"22 mm (LxWxH)
Weight: Power input:
0,4"kg 5"V 500"mA (2,5"W) from USB Continuous Measuring sound propagation speed range: 3200"–"4300 m/s
Accuracy of measurement:
+/- 50 m/s Ultrasound Sensor (line sensor 4 elements, ~200 kHz) Serial number is on the underside of the table top unit. There are no electrical contacts to patient. Protection against electrical shock is class II BF-type
Transportation and storage:
Temperature 0–70 °"C Relative humidity of 30–75"% Pressure 500–1060 mbar
Operating conditions:
Temperature 10"–"36 °"C Relative humidity 30–75"% Pressure 800–1060 mbar
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OSCARE MEDICAL OY Kutomotie 4 00380 Helsinki Finland www.oscaremedical.fi
[email protected]