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PTH and Alendronate: combining treatments shows no bone density advantage

Combining the bone-building treatment parathyroid hormone (PTH) with alendronate, a drug that slows bone loss, produces no significant improvement in bone mineral density (BMD) beyond that produced by the individual drugs, according to two new studies involving postmenopausal women and men with low BMD.

The two studies, reported in the September 25 issue of the New England Journal of Medicine and supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the National Institutes of Health, both tested BMD in the spine and hip. BMD, a common indicator of bone health, is used to diagnose the bone-weakening disease osteoporosis, detect low bone mass before the disease develops and help predict the risk of future fractures.

Although clinicians had hoped to optimize osteoporosis treatment and increase BMD by combining the two potent medications, the two trials show that PTH alone increases BMD at least as well as or better than combination therapy. Further studies, say some scientists, are needed to see if the optimal effects of these drugs might be achieved by sequential or cyclic therapy. A comparative study of fracture rates would also be needed to assess drug effectiveness.

"Both patients and physicians benefit from knowing how the combination compares to single drug treatment," said NIAMS Director Stephen I. Katz, M.D., Ph.D. "These findings could offer important clinical guidance to those at high risk for fractures and those who treat them."

One study, a randomized, blinded clinical trial involving 238 postmenopausal women with low hip or spine BMD, was carried out at four centers and coordinated at the University of California San Francisco by Dennis Black, M.D., and his colleagues. In the study, featured at the recent meeting of the American Society for Bone and Mineral Research in Minneapolis, the women were given a daily regimen of PTH, alendronate, or a combination of the two. After 12
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Contact: Ray Fleming
flemingr@mail.nih.gov
301-496-8190
NIH/National Institute of Arthritis and Musculoskeletal and Skin Diseases
3-Oct-2003


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