For in vitro diagnostic use as an indicator of human bone resorption. This test may be used as an aid in monitoring bone resorption changes of antiresorptive therapies in postmenopausal women, individuals with osteopenia, and in predicting skeletal response (bone mineral density) in postmenopausal women undergoing antiresorptive therapies.

• Hormone replacement therapies (HRT) with hormones and hormone-like drugs

• Bisphosphonate therapies

This test is not intended to predict the development of osteoporosis or future fracture risk. The use of this test has not been established in hyperparathyroidism or hyperthyroidism. When using the test to monitor therapy, results may be confounded in patients afflicted with clinical conditions known to affect bone resorption (eg, bone metastases, hyperparathyroidism, or hyperthyroidism). Results should be interpreted in conjunction with clinical findings and other diagnostic results and should not be used as a sole determination in initiating or changing therapy. Note: Serum values are not interchangeable with urine values.