Register for Analysis shows early response to FORTEO in postmenopausal women
OsteoporosisJuly 12, 2004
2004 JUL 12 - (NewsRx.com & NewsRx.net) -- Changes in markers of bone remodeling after 1 month of treatment with FORTEO (teriparatide [rDNA origin] injection) may provide important early evidence of treatment response, according to new data presented at the 86th annual meeting of The Endocrine Society.
The Fracture Prevention Trial (FPT), a registration trial for FORTEO, was a randomized, double-blinded, placebo-controlled study that enrolled 1637 women with osteoporosis. Subjects were randomized to FORTEO 20 mcg/day, (the currently approved and marketed dose), FORTEO 40 mcg/day, or placebo for a median of 19 months.
The subanalysis of 527 patients from the FPT (previously published in New England Journal of Medicine, May 2001) found that as early as 1 month into treatment, changes in markers of bone remodeling, particularly serum carboxy-terminal propeptide of type I collagen, provided important predictive information of subsequent bone mineral density (BMD) increases in response to FORTEO. BMD is used to both diagnose osteoporosis and monitor treatment effectiveness. Unlike BMD measurements, markers of bone remodeling are able to detect delicate changes in the bone early in the treatment cycle - sometimes within weeks of beginning a treatment.
"These findings are significant because they provide physicians and patients early evidence that treatment with FORTEO is working," said Lead Investigator Dr. Angelo Licata, endocrinologist with the Cleveland Clinic. "Providing physicians and patients with this information early in their treatment is crucial in that it may help promote compliance, a common roadblock in osteoporosis treatment."
FORTEO stimulates new bone formation by increasing the number and activity of bone-forming cells called osteoblasts. FORTEO is approved for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2004, Biotech Business Week via NewsRx.com & NewsRx.net.
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