HONOLULU, Hawaii, September 19 /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-professionals/about-oste.... Last accessed September 2007.
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
