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 Volume
in Patients on Long Term Bisphosphonate Treatment

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 #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
#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-profe
ssionals/about-osteoporosis/epidemiology.html. Last accessed
September 2007.

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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