The U.S. Food and Drug Administration (FDA) has cleared a new automated blood test to help prevent and treat osteoporosis and Paget’s disease, two severe bone diseases.  The new blood test measures a patient’s bone metabolism and helps determine whether significant bone loss has occurred or if a particular osteoporosis therapy (such as hormone replacement therapy ) is working effectively. 

According to Beckman Coulter, Inc., the maker of the Access Ostase blood test, the automated blood test can produce results in little as 20 minutes, compared to a few hours required with manual blood tests.  The automated blood test is less expensive than bone mineral density tests such as DEXA or ultrasound and can be used to assess the rate of bone metabolism in three to six months after osteoporosis treatment begins. 

Consequently, physicians can quickly determine if a certain treatment such as hormone replacement therapy, raloxifene (brand name, Evista), alendronate (brand name, Fosamax) or calcitonin (brand name, Miacalcin) is rebuilding bone mineral density.  Bone mineral density changes can occur slowly, sometimes making it difficult to determine whether a particular therapy is working a year to two years with traditional bone mineral density tests.  In that time, up to 8% of a woman's bone mass can be lost.

The new automated blood test determines a patient’s bone metabolism by measuring the level of a certain enzyme in the blood called bone-specific alkaline phosphatase (BAP).  If a particular osteoporosis therapy is not working, physicians may be able to tell within a matter of months and prescribe a new therapy.

Osteoporosis is a degenerative bone disease affecting roughly 25 million Americans, mostly post-menopausal women.  Osteoporosis is currently one of the most under-diagnosed and under-treated disorders in medicine.  It is estimated that one-third of women over age 50 have osteoporosis.  Osteoporosis is characterized by a decrease in normal bone density due to the loss of calcium and collagen. A loss of bone density causes bones to become brittle, and in turn, leads to frequent fractures and other serious effects.  Osteoporosis accounts for more than 2.3 million fractures per year in the United States and Europe.

Paget’s disease is a crippling bone disorder far less common than osteoporosis.  Normally, bone is constantly being broken down by cells called osteoclasts and rebuilt by cells called osteoblasts.  With Paget’s disease, this process becomes unbalanced.  Common deformities of Paget’s disease include bowed legs, an enlarged head or pelvis, and a curved back. 

Additional Resources and References

•  The April 19, 2000 Beckman Coulter press release, “Beckman Coulter Access Ostase Blood Test Cleared by FDA, Automated Assay Benefits Women with Postmenopausal Osteoporosis,” is available at http://www.beckman.com/News/ostase.asp
• The April 19, 2000 Reuters Health report, “Beckman Coulter’s Osteoporosis Test Cleared by FDA,” is available at http://biz.yahoo.com/rf/000419/fi.asp

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