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Ibandronate-induced Bone Mineral Density Increases Spur Fracture Reduction: Presented at ASBMR
By Bonnie Darves
SEATTLE, WA -- October 6, 2004 -- The role of bisphosphonates in increasing bone mineral density (BMD) is widely accepted, but the relationship between that BMD gain and fracture risk, which was not well understood, has been clarified by results of a phase 3 study.
The study, presented here October 4th at the American Society for Bone and Mineral Research annual meeting, suggest that intravenous ibandronate therapy reduces fracture risk.
The researchers found that after 2 and 3 years of treatment, a 1% total-hip BMD increase predicted a 9.8% and 7.9% reduction in fracture risk, respectively, said co-author Saul Epstein, MD, Mount Sinai Medical Center, New York. A corresponding increase in lumbar spine BMD also predicted a reduction in vertebral fracture risk 3 years after initiation of treatment.
The findings, Dr. Epstein said, show that patients whose total hip and lumbar spine BMD is increased are more likely to have a reduced risk of fracture. The findings also help to elucidate the relationship between increases in total hip BMD and lumbar spine BMD and fracture risk.
The study involved in-depth analysis of data from a phase 3, randomized study that enrolled 1,609 women who received a 0.5 mg or 1 mg IV injection of ibandronate or placebo every 3 months. In their analysis, the authors used data from the patients who met criteria for inclusion in the per-protocol population and whose lumbar spine (L2-L4) BMD T-score was less than -2 at baseline.
When researchers employed a moving averages analysis, they found a 16% rate of vertical fracture in patients with a -3% BMD change compared with 5% rate in those whose BMD increased by more than 4%.
[Presentation title: "Change in Bone Mineral Density Is Predictive for Fracture Risk Reduction With Ibandronate: Further Insights From a Phase III Study of Intravenous Ibandronate Injection." Abstract SU441]
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