were taken at baseline and at three years in 19 post-menopausal women who received either Actonel or placebo. In subjects treated for three years with placebo (n=8) there were statistically significant increases in both the mineral crystallinity (0.92 +/-06 at baseline vs. 1.22 +/- 0.04 at three years) and collagen cross-link ratio (1.40 +/- 0.20 at baseline vs. 1.90 +/- 0.04 at three years). In contrast, these parameters did not significantly change in the patients treated for three years with Actonel (n=11). Crystallinity before and after three years of treatment was 1.00 +/- 0.11 and 0.93 +/- 0.06, respectively. Collagen cross-link ratio before and after treatment was 1.61 +/- 0.40 and 1.61 +/- 0.86, respectively.

Eight of the Actonel patients had an additional biopsy performed after five years of treatment, and again the two bone quality parameters of crystallinity and collagen cross-link ratio had not changed from baseline. The crystallinity measurements before and after five years of treatment were 1.00 +/- 0.11 and 0.93 +/- 0.04, respectively. The collagen cross-link ratios before and after treatment were 1.61 +/- 0.40 and 1.64 +/- 0.52, respectively.

About Osteoporosis
Osteoporosis is a disease characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation (NOF), 8 million women in the U.S. have osteoporosis, and 1.2 million osteoporotic fractures occur annually. The NOF estimates that every 20 seconds an osteoporosis-related fracture occurs. Risk factors for osteoporosis in postmenopausal women include age, personal history or family history of fracture, low bone mineral density, cigarette use, and race.

Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade. Frac
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22-Sep-2003

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