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UC researcher utilizes historical control group for new osteoporatic fracture analysis

es matched placebo patients from previous Actonel clinical studies with patients from the once-a-week study, based on key baseline characteristics that contribute to fracture risk. Dr. Watts is an advocate for historical controls, because they eliminate some of the ethical dilemmas of using a placebo in clinical trials.

This analysis compared historical placebo control patients (n = 114) from the risedronate Phase III vertebral fracture studies with patients (n = 402) receiving once-a-week Actonel 35 mg. At one year, the relative risk of new vertebral fractures with Actonel 35 mg once-a-week treatment was 0.23 (95 percent confidence interval, 0.05 to 0.910; p-value = 0.018) compared to the historical placebo control.

According to the World Health Organization (WHO), osteoporosis is a significant and growing public health problem. The National Osteoporosis Foundation estimates that, in the United States, approximately 40 percent of women over 50 will experience a fracture due to osteoporosis in their lifetimes. Postmenopausal osteoporosis, caused by estrogen deficiency that typically occurs at menopause, is the most common form of osteoporosis.

"Fracture prevention is the primary goal of osteoporosis treatment and these data offer more support of the rapid and consistent fracture benefits demonstrated by treatment with Actonel, " said Dr. Watts. "It is especially important to reduce the risk of fracture quickly, because one in five women who have experienced a vertebral fracture will fracture again within one year, potentially resulting in a cascade of spinal fractures."


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Contact: Brian Devenny
bdevenny@hillandknowlton.com
212-885-0315
Hill and Knowlton
21-Jun-2002


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