Norland Elite 437A150, Operator'S Manual

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Operator's Guide
437D140 Rev. I
Reference Data Sets 18-3
Medical History Form Review Criteria
The Medical History form provided the information needed to determine whether a given individual should be
included in the Normal Group or excluded in the Osteoporotic Group, or excluded from the study entirely. Since
some medications significantly affect bone mass, interpretation was necessary to evaluate a particular drug’s
effect (based on dose, duration and time of life). Interpretation was also necessary to evaluate the effect of cer-
tain bone-active disorders. The following paragraphs provide guidance when evaluating the Medical Histories.
Osteoporosis
Data obtained from subjects diagnosed with osteoporosis was not used in Norland normative data but was
saved for potential future, yet to be determined studies.
Other Bone-Active Diseases and Conditions
The diseases and conditions on the following page are listed in the Medical History form and provide possible
grounds for exclusion from the study. Exclusion criteria was established to ensure the collection of bone dens-
ity measurements from normal, healthy, untreated individuals.
Amenorrheic Syndrome: Exclusion only if syndrome was prolonged (at least 2 years), and recent (within the
last three months).
Alcoholism: Exclusion only if severe, chronic, and accompanied by malnutrition. If possible, quantify amount
of alcohol consumption.
Alzheimer’s: Not grounds for exclusion.
Births: Number of births means number of pregnancies.
Broken/Fractured Hip: Not grounds for exclusion if occurred more than five years prior to data collection.
Cancer: Subject data may be included, as long as subject has been cancer free for more than five years. Local-
ized squamous and basal cell are often not exclusions.
Cirrhosis: Exclusion only if clinically apparent and duration is greater than 3 months.
Cushing’s Syndrome: Grounds for exclusion.
Diabetes: Exclusion only if onset occurred in childhood, delaying or retarding growth. Properly treated adult dia-
betics need not be excluded.
Early Menopause: Not grounds for exclusion. Early menopause is considered to be before 40 years of age.
Make sure that the date of menopause is included for later analysis.
Emphysema: Exclusion if clinically apparent and/or severe COPD.
Fractures: Fractures due to accidents and trauma are not grounds for exclusion. Vertebral and other spon-
taneous fractures are grounds for exclusion.
Hyperparathyroidism: Data collected from these subjects will be excluded.
Hypoparathyroidism: Data collected from these subjects will be excluded.
Hyperthyroidism: If medication (dose) has been stable for 12 consecutive months, data need not be excluded.
Hypogonadism (Males): Grounds for exclusion.
Hypothyroidism: If medication (dose) has been stable for 12 consecutive months, data need not be excluded.
Hysterectomy: Hysterectomy with bilateral oophorectomy will be excluded.
Immobilization: Exclusion only if immobilization is prolonged for longer than one month, such as in stroke vic-
tims.
Leukemia: Grounds for exclusion.
Liver Disease: Exclusion only if clinically apparent and duration is greater than 3 months.