2007-09-19

New Data Confirm Clear Benefit of Protelos(R) (Strontium Ranelate) in the Treatment of Postmenopausal Osteoporosis


Honolulu, Hawaii (ots/PRNewswire) -

- Protelos(R) Relaunches Bone Formation and Increases Bone Volumein Patients on Long Term Bisphosphonate Treatment

Protelos(R) (strontium ranelate) stimulates bone formation andincreases bone volume by 30% in high fracture risk patients who havebeen on long term bisphosphonate therapy, according to new datapresented today at the 29th American Society for Bone and MineralResearch (ASBMR) meeting.(1)

Several medications have proved effective in reducing fracturerisk in patients with osteoporosis. However, certain treatments, suchas the bisphosphonates, actually suppress bone turnover and theirlong term use has been questioned. The new study presented by Busseet al shows that Protelos re-launches bone formation even when boneturnover is suppressed by long term bisphosphonate treatment.

The new data from paired bone biopsies show that, one year afterProtelos therapy, bone volume is significantly increased by 30% andtrabecular thickness by 10%. Moreover, active bone formation sitesare increased with beneficial effects on bone quality.

These results confirm Protelos' innovative dual mechanism ofaction. Indeed, unlike other osteoporosis treatments, Protelossimultaneously increases bone formation and decreases boneresorption,(2) rebalancing bone turnover in favour of the formationof new and stronger bone.

Protelos: major anti-fracture efficacy in young post-menopausalosteoporotic women

New data from the SOTI trial showed that Protelos has significantvertebral anti-fracture efficacy in young postmenopausal osteoporoticwomen aged between 50 and 65 years, confirming the benefit ofProtelos, whatever the age of the patients.(3),(4)

The placebo-controlled study investigated the efficacy of Protelosin women aged between 50 and 65 years (n=353). Over 3 years oftreatment, Protelos significantly reduced the risk of vertebralfracture by 47% (p=0.006) compared to placebo. The incidence ofvertebral fractures over 3 years was 16.9% in the Protelos groupcompared to 29.6% in the placebo group. These results are in linewith those of the whole Phase III SOTI population.(3)

This data is important as early protection against vertebralfractures is a key goal of anti-osteoporosis treatment. Patients witha history of vertebral fracture have a 2.3-fold increased risk offuture hip fracture and a 1.4-fold increase in risk of distal forearmfracture,(5) and the incidence of vertebral fractures rises withage.(6)

"These results demonstrate the huge clinical value of strontiumranelate in younger postmenopausal women," says study authorProfessor Devogelaer from Hospital Universitaire St. Luc, Brussels,Belgium. "Early fractures occurring within the first 10 years aftermenopause have a great impact on the further progression of thedisease, as it has been shown that the first osteoporotic fracture isa major risk factor for further additional fractures. Subsequently,the anti-fracture efficacy of strontium ranelate in younger femalesaged less than 65 years is of utmost interest."

Protelos is licensed for the treatment of postmenopausalosteoporosis to reduce the risk of vertebral and hip fractures. It isregistered in 84 countries worldwide and launched in 60 countries.Protelos is also sold under the trade names Protos, Osseor, Bivalos,Protaxos, Ossum.

References:

(1). Busse B, Priemel M, Jobke B, Hahn M, Zustin J, Semler J,Amling M. Bone biomechanics and quality: Changes in bone quality inuntreated and treated osteoporosis. ASBMR 2007 abstract #W477.

(2). Marie PJ, Ammann P, Boivin G, et al. Mechanisms of action andtherapeutic potential of strontium in bone. Calcif Tissue Int.2001;69:121-129.

(3). Devogelaer JP, Roux C, Isaia G, Cannata Andia JB. Strontiumranelate reduces the risk of vertebral fracture in youngpostmenopausal women with severe osteoporosis. ASBMR 2007 abstract#T412.

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

(5). Melton III LJ, Atkinson EJ, Cooper C, O'Fallon WM, Riggs BL.Vertebral fractures predict subsequent fractures. OsteoporosisInt 1999;10:214-21.

(6). International Osteoporosis Foundation. About Osteoporosis :Epidemiology. Available at: http://www.iofbonehealth.org/health-professionals/about-osteoporosis/epidemiology.html. Last accessedSeptember 2007.

ots Originaltext: ServierIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information or to arrange an interview with Professor Devogelaer, please contact: Moira Gitsham, tel: +33-5-46-00-08-20, mob: + 33-20-74-01-92 email: moira.gitsham@toniclc.com; Elizabeth Walters, tel: +44-207-798-9900, email: elizabeth.walters@toniclc.com

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New Data Confirm Clear Benefit of Protelos(R) (Strontium Ranelate) in the Treatment of Postmenopausal Osteoporosis

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