Servier reports promising Protelos study data at the 6th annual ECCEO in Vienna

26 March 2006

New data presented at the 6th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis held this year in Vienna, Austria, show that Protelos (strontium ranelate), for the treatment of osteoporosis has sustained efficacy against both vertebral and non-vertebral fractures in postmenopausal osteporotic women. The drug, which is produced by French independent pharmaceutical firm Servier, is designed to rebalance bone turnover in favor of formation, leading to an increase in bone-mineral density and therefore bone mass. Its dual mode of action is unique, with an increase in bone formation and a decrease in bone resorption. The product first gained approval in the European Union in late 2004 (Marketletter November 1, 2004).

Data derived from two long-term trials

The data is derived from two landmark studies of the drug; these were the spinal osteoporosis therapeutic intervention trial (SOTI) and the treatment of peripheral osteoporosis study (TROPOS). Data from both programs were analyzed after three years although both assessments continued for a period of five years, allowing Servier to obtain the requisite efficacy and safety information.

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