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
