Description of Treatment/Procedure

Osteoporosis is a metabolic bone disease that is characterized by abnormalities in the amount and architectural arrangement of bone tissue which lead to impaired skeletal strength and an increased susceptibility to fractures. The decreased bone mass associated with osteoporosis is likely the result of an imbalance between bone resorption and bone formation. Biochemical markers of bone turnover are indicative of the overall bone metabolism and provide different information than that obtained from measurements of bone mineral density (BMD). In testing biochemical markers, it is important to consider that there is a high degree of variability associated with measurement of the markers (especially urinary markers).

Committee Summary

With regard to the use of biochemical markers of bone turnover in osteoporosis, the ICSI Technology Assessment Committee finds the following:

1. The assessment of serum and urine biochemical markers of bone turnover is safe and minimally invasive.
   
2. While there is some population based evidence that increased values for biochemical markers are associated with increased fracture risk and that uncoupling of the bone formation/resorption mechanism is greater in fracture cases, it is not possible to predict an individual’s fracture risk from biochemical marker measurements. A combination of bone mineral density and biochemical marker measurements may be of greater value but the data are inconclusive. (Conclusion Grade II)
   
3. Although population trends have been observed, biochemical markers do not have adequate sensitivity and specificity to predict osteoporosis in individual, untreated patients. The diagnosis of osteoporosis is based on a reduced BMD and/or the presence of fragility fractures. (Conclusion Grade II)
   
4. Several biochemical markers are responsive to various therapeutic options. However, there is no conclusive evidence that biochemical markers may be used to assist in selecting the type of therapy or to predict the amplitude of the BMD response for an individual patient. (Conclusion Grade II)
   
5. Although biochemical markers have the potential to be used to motivate individuals to maintain a therapy program, there are no studies of the use of biochemical markers for this purpose.