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

     Protelos(R) Relaunches Bone Formation and Increases Bone Volume in
     Patients on Long Term Bisphosphonate Treatment

HONOLULU, Sept. 19 /CNW/ - Protelos(R) (strontium ranelate) stimulates
bone formation and increases bone volume by 30% in high fracture risk patients
who have been on long term bisphosphonate therapy, according to new data
presented today at the 29th American Society for Bone and Mineral Research
(ASBMR) meeting.(1)

     Several medications have proved effective in reducing fracture risk in
patients with osteoporosis. However, certain treatments, such as the
bisphosphonates, actually suppress bone turnover and their long term use has
been questioned. The new study presented by Busse et al shows that Protelos
re-launches bone formation even when bone turnover is suppressed by long term
bisphosphonate treatment.

     The new data from paired bone biopsies show that, one year after Protelos
therapy, bone volume is significantly increased by 30% and trabecular
thickness by 10%. Moreover, active bone formation sites are increased with
beneficial effects on bone quality.

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

     Protelos: major anti-fracture efficacy in young post-menopausal
     osteoporotic women

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

     The placebo-controlled study investigated the efficacy of Protelos in
women aged between 50 and 65 years (n=353). Over 3 years of treatment,
Protelos significantly reduced the risk of vertebral fracture by 47% (p=0.006)
compared to placebo. The incidence of vertebral fractures over 3 years was
16.9% in the Protelos group compared to 29.6% in the placebo group. These
results are in line with those of the whole Phase III SOTI population.(3)
     This data is important as early protection against vertebral fractures is
a key goal of anti-osteoporosis treatment. Patients with a history of
vertebral fracture have a 2.3-fold increased risk of future hip fracture and a
1.4-fold increase in risk of distal forearm fracture,(5) and the incidence of
vertebral fractures rises with age.(6)

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

     Protelos is licensed for the treatment of postmenopausal osteoporosis to
reduce the risk of vertebral and hip fractures. It is registered 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 in untreated and
     treated osteoporosis. ASBMR 2007 abstract No.W477.
     (2). 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.
     (3). Devogelaer JP, Roux C, Isaia G, Cannata Andia JB. Strontium ranelate
     reduces the risk of vertebral fracture in young postmenopausal women with
     severe osteoporosis. ASBMR 2007 abstract No.T412.
     (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). Melton III LJ, Atkinson EJ, Cooper C, O'Fallon WM, Riggs BL.
     Vertebral fractures predict subsequent fractures. Osteoporosis Int
     1999;10:214-21.
     (6). International Osteoporosis Foundation. About Osteoporosis :
     Epidemiology. Available at:
     http://www.iofbonehealth.org/health-professionals/about-osteoporosis/epid
emiology.html.
     Last accessed September 2007. (Due to the length of this URL, it may be
     necessary to copy and paste this hyperlink into your Internet browser's
     URL address field. Remove the space if one exists.)

 

-30-

/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/

Posted: September 2007

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