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Significant Long Term Efficacy of Protelos(R) (Strontium Ranelate) Confirmed

    Vienna, Austria (ots/PRNewswire) -

    - New Data Demonstrate "Unique", Five Year Anti-Osteoporotic Efficacy Against Both Vertebral and Non-Vertebral Fractures

    New five year data presented at the 6th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO 6) meeting today show that the new osteoporosis treatment Protelos(R) (strontium ranelate, Servier) has sustained efficacy against both vertebral and non-vertebral fractures in postmenopausal osteoporotic women.(1) In particular, the new data demonstrate a significant reduction in the risk of new vertebral fracture by up to a third in patients receiving Protelos compared to those receiving placebo.

    "These long term results demonstrate that Protelos is unique among osteoporosis treatments", says lead study investigator Professor J-Y Reginster from the University of Liège in Belgium. "Protelos is the first and only anti-osteoporotic treatment to show five-year, evidence-based efficacy against both vertebral and non-vertebral fractures and should be considered for sustained first-line therapy in women with postmenopausal osteoporosis."

    These long-term efficacy results are of particular interest when we know that one-year adherence rates of current therapies, mainly bisphosphonates, are less than 25%.(2)

    Protelos, first approved in the EU in September 2004 to reduce the risk of vertebral and hip fractures in patients with postmenopausal osteoporosis, is a novel anti-osteoporotic treatment with an innovative dual mechanism of action. Unlike other osteoporosis treatments, Protelos both increases bone formation and decreases bone resorption.(3) This unique action on bone metabolism allows the natural process of bone remodelling (bone resorption and bone formation) to continue in such a way that bone turnover is rebalanced in favour of the formation of new and stronger bone.

    SOTI and TROPOS

    In its Phase III drug development programme, two double-blind, placebo-controlled studies were performed in Caucasian women with postmenopausal osteoporosis in 75 European and Australian centres - SOTI (Spinal Osteoporosis Therapeutic Intervention, n= 1649) and TROPOS (Treatment Of Peripheral Osteoporosis, n=5091).(4,5) The main analysis of these study results was completed after three years and demonstrated the efficacy of Protelos at vertebral and non-vertebral sites and also specifically at the hip level (5). Both studies, however, were continued for five years to obtain long term efficacy and safety data.

    In SOTI, patients were randomised to receive Protelos 2g per day or placebo for four years. During a further fifth year, half the Protelos group received placebo while the other half continued their active treatment. The long term efficacy data confirmed a significant reduction in the risk of new vertebral fracture by 33% in the Protelos group (n=719) as compared to the placebo group (n=723) in the intention to treat population over four years treatment (relative risk (RR) = 0.67, p<0.001).

    In TROPOS, patients were randomly assigned to receive Protelos 2g per day or placebo for five years. Protelos was found to be significantly more efficacious than placebo with a 24% reduction in vertebral fracture (RR 0.76, p<0.001) and a 15% reduction in non-vertebral fracture (RR 0.85, p=0.03) in the intention to treat population (n= 2479 in the Protelos group and n = 2453 in the placebo group).

    Throughout its clinical development programme, Protelos has been shown to be well tolerated and easy to use for patients.(6)

    Protelos is licensed in Europe for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures in patients with or without a previous history of fractures. It is now available in 30 countries worldwide, including Germany, the UK, Spain, Italy, France and Ireland.

    Other trade names for Protelos are: Osseor(R), Protos(R), Protaxos(R), Bivalos(R)

    References:

    1. 1. Reginster JY. Strontium ranelate: an antiosteoporotic treatment demonstrated vertebral and nonvertebral antifracture efficacy over 5 years in postmenopausal osteoporotic women. Oral communication, ECCEO 6 2006, Vienna, Austria.

    2. 2. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J. Compliance with drug therapies for the treatment and prevention of osteoporosis. Maturitas 2004;48:217-287.

    3. 3. Marie PJ, Ammann P, Boivin G, et al. Mechanisms of action and therapeutic potential of strontium in bone. Calcif Tissue Int. 2001;69:121-129.

    4. 4. Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med.2004;350:459-468.

    5. 5. Reginster JY, Seeman E, De Vernejoul MC, et al. Strontium ranelate reduces the risk of nonvertebral fractures in post-menopausal women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) Study. J Clin Endocrinol Metab. 2005; 90(5). 2816-2822.

    6. 6. Protelos European Summary of Product Characteristics.

ots Originaltext: Servier
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information or to arrange an interview with Professor
Reginster, please contact: Moira Gitsham, tel +33-5-46-00-08-20, mob:
+33-6-20-74-01-92 email: moira.gitsham@toniclc.com Kristin O'Leary,
tel +44-207-798-9900, email: kristin.oleary@toniclc.com



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