Register for Actonel significantly reduces fractures in high-risk women
OsteoporosisMarch 6, 2003
2003 MAR 6 - (NewsRx.com & NewsRx.net) -- Newly published data show that treatment with 5 mg Actonel (risedronate sodium tablets) daily reduced the risk of spinal fracture in postmenopausal osteoporotic patients at higher risk of fracture because of age or low bone mineral density (BMD) at the hip.
In these patients, fracture risk was reduced by 62% and 60%, respectively, at 1 year with Actonel compared with placebo. The analysis of combined data from two studies was published in the Journal of Clinical Endocrinology and Metabolism, and also shows that the fracture reduction benefits of Actonel in patients at higher risk of fracture were similar to the benefits observed in the overall populations of patients with established osteoporosis.
"The ultimate goal of osteoporosis treatment is to prevent fractures. Providing rapid fracture prevention is critical to a high-risk patient group that, if left untreated, is likely to fracture soon," said Nelson Watts, MD, director of the University of Cincinnati Bone Health Center. "In this analysis, significant reductions in fracture risk were seen at one year with Actonel and underscore the importance of early identification and treatment of patients at high risk for fracture."
To determine the effect of Actonel on new spinal fractures in patients at high risk of fracture, data were pooled from two randomized, double-blind studies (VERT-MN and VERT-NA) in 2,457 postmenopausal osteoporotic women treated with placebo or Actonel 5 mg daily. All women received 1000 mg per day calcium and up to 500 IU per day of vitamin D. A post hoc analysis evaluated fracture risk at one year in patients at high risk of fracture, defined in this analysis as age >70 years or low hip BMD (T score <-2.5, based on the World Health Organization definition of osteoporosis).
In the subgroup of patients >70 years of age, the incidence of new spinal fractures was 10.8% in the placebo group compared with 4.4% in the Actonel group, representing a fracture risk reduction in the Actonel-treated patients of 62% versus placebo (p<0.001). Among patients with low hip BMD, the incidence of new spinal fractures at 1 year was 12.8% in the control group, compared with 5.6% in the Actonel group, reflecting a reduction in fracture risk in the Actonel patients of 60% vs. control (p<0.001). The fracture risk reductions in the high-risk subgroups with Actonel were similar to those seen in the overall population included in the analysis. In the overall population, the incidence of new spinal fractures at one year was 8.8% in the control group compared to 3.5% in the Actonel group - a 62% fracture risk reduction with Actonel (p<0.001) (Watts NB, Josse RG, Hamdy RC, et al., Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab, 2003;88(2):542-9).
These findings are also consistent with 1-year spinal fracture reductions seen in other Actonel clinical trials. This article was prepared by Women's Health Weekly editors from staff and other reports.
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