San Diego, Calif. (November 17, 2006) Treatment with the phosphate binder FOSRENOL(R) (lanthanum carbonate) was associated with slight improvements in bone formation in chronic kidney disease (CKD) Stage 5 patients with hyperphosphatemia (high phosphorus levels in the blood), according to long-term (two-year) data presented at the American Society of Nephrology (ASN) meeting. Additional studies presented at ASN document the efficacy and safety of the reformulated and higher-dose FOSRENOL tablets.
Of the approximately 20 million Americans who have some form of kidney disease, more than 530,000 have developed CKD Stage 5. Even with dialysis and a low-phosphorus diet, most CKD Stage 5 patients in the United States will develop hyperphosphatemia. Without effective treatment, hyperphosphatemia may lead to renal osteodystrophy, a collection of bone diseases characterized by bone pain, brittle bones, skeletal deformities and fractures.
"Renal osteodystrophy develops early during chronic kidney disease, so by the time many patients reach dialysis, they may have painful and debilitating bone conditions. Treating hyperphosphatemia through diet and an effective phosphate binder can help patients maintain bone health while on dialysis," explained Hartmut H. Malluche, M.D., study author and chief of Nephrology, Bone and Mineral Metabolism in the Department of Internal Medicine at the University of Kentucky College of Medicine. "Our study showed that FOSRENOL treatment was associated with increased bone formation in participants and that there were no signs of bone abnormalities, such as progressive evolution of mineralization defects or decreases in bone turnover."
This planned sub-study of a large Phase III clinical trial evaluated potential differences between standard therapy and lanthanum carbonate on the evolution of abnormalities of bone turnover, bone balance and mineralization in patients with CKD Stage 5. Investigators used bone bi
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