Norland Elite 437A150, Operator'S Manual

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Data Collection Sites
For the Norland reference sets, the data was gathered at ten (10) study sites across the USA. The ages of the
subjects scanned was from 20 to 89 years of age. All scan data was examined to verify acceptable quality
(proper positioning, correct region placement, etc.). The numerical values for these subjects are listed in Table
1 in this document.
Data is provided for Female Caucasians for the Total Hip sBMD region as derived from phases 1 and 2 of the
third National Health and Nutritions Examination Survey (NHANES III, 1988-1994). Reference values for this
set are listed in Table 18-2 on page 18-15. The values were generated following the formula published in
the Journal of Bone and Mineral Research (see page 18-8 of this chapter). The formula used is:
sBMD = 1000(1.012 * BMD
Norland
+ 0.026)
Data is also provided for Female Caucasians for the Spine L2-L4 sBMD region as derived from phases 1 and 2
of the third National Health and Nutritions Examination Survey (NHANES III, 1988-1994). The values were gen-
erated following the formula published in Calcified Tissue International (see page 18-7 of this chapter). The for-
mula used is:
sBMD = 1000(1.0761 * BMD
Norland
)
Data Gathering Process
Information needed to determine appropriate classification into a particular sex and ethnic reference set was
obtained from a self-reported detailed medical history required of all study participants. Information was noted
on Medical History forms and verified by Norland selected investigators. Categories included height, weight,
ancestry (ethnicity), occupation, diet, family history, medical and surgical history, and so forth. Ethnic indi-
viduals had to be at least 75% of the claimed ethnic background as self-reported.
Based on review of the medical history information, only data from normal, healthy, untreated individuals was
included in each Reference Set. Individual participants having certain conditions and/or medication were
included after consideration of each specific situation. Included individuals are grouped by sex, age, and ethnic
background. Care was taken to include a significant amount of data from those in the younger age range, as
well as a broad distribution of participants across all age ranges.
Data from those participants who reported illnesses or medication affecting the subject’s bone health was
excluded from the reference sets. Any of the diseases and conditions listed below (and on the Medical History
form) were possible grounds for exclusion from the study. Data from participants with diagnosed osteoporosis
[defined as those individuals who have x-ray evidence of vertebral fracture (including DXA scan), hip fracture
associated with osteoporosis, loss of height, or other specified means] was not used in Norland reference sets.
Completed studies were examined by Norland QA to verify acceptable scan quality for inclusion in the ref-
erence set. Finally, subject information was reviewed by the clinical auditor to ensure that the complete clinical
history met all the inclusion criteria.
Operator's Guide
437D140 Rev. I
18-2 Reference Data Sets