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Protelos(R): First Osteoporosis Treatment to Show Long-Term, Sustained Efficacy and Quality of Life Improvement

Copenhagen, Denmark (ots/PRNewswire)

- New Data Show Clear Benefit of Protelos(R) in Wide Range of
Osteoporosis Patients Irrespective of Disease Severity
New, long term data presented at the 34th European Symposium on
Calcified Tissues (ECTS) this week underscore the unmatchable,
long-term efficacy and quality of life improvement offered by the
anti-osteoporotic treatment, Protelos(R) (strontium ranelate). These
data also provide evidence to show that Protelos has clinical benefit
in a broad range of osteoporotic patients, irrespective of their
level of bone turnover and severity of their disease.
Protelos is a new anti-osteoporosis treatment with a unique mode
of action both increasing bone formation and decreasing bone
resorption. For the first time, new data have shown sustained, five
year efficacy against vertebral and non-vertebral fractures,
including hip fractures(1). Protelos is also the first treatment to
show an improvement in the quality of life of patients with vertebral
postmenopausal osteoporosis over four years(2).
Five year efficacy(1)
Five year data on the long term antifracture efficacy of Protelos
from the TROPOS (TReatment Of Peripheral OSteoporosis) study show
that, uniquely for an anti-osteoporotic treatment, Protelos provides
sustained five year efficacy against vertebral, non vertebral and hip
fractures. The phase III study, run across 75 European and Australian
centres involved over 5,000 women with postmenopausal osteoporosis
with mean age of 76 given either 2g daily of Protelos or placebo for
five years. All patients also received calcium and vitamin D
supplements according to their needs.
The five year results revealed a 24% reduction in vertebral
fracture (p<0.001) and 15% reduction in non-vertebral fracture
(p<0.03) in the intent-to-treat population. Additionally, there was a
43% reduction of the risk of hip fracture in women who had a higher
risk of fractures (74 years and older with a low lumbar and femoral
neck bone mineral density T-score, p<0.036).
Quality of life(2)
Vertebral fractures can lead to a significant downturn in
patients' health-related quality of life (HRQoL).
The SOTI (Spinal Osteoporosis Therapeutic Intervention) study, a
double-blind placebo-controlled study carried out in 1649
postmenopausal osteoporotic women, measured the impact of Protelos on
HRQoL for four years. In this study, women were given 2g daily of
Protelos or placebo.
At the end of the four year period, the Protelos group achieved
significantly more positive QoL scores than the placebo group. This
group also demonstrated improved QoL compared to a deterioration of
QoL in the placebo group. Also, the number of patients who did not
suffer from back pain was 28% higher in patients on Protelos compared
with those on placebo (p=0.005). The women were assessed every six
months, using both a general QoL questionnaire and QUALIOST(R), a
specific vertebral osteoporosis questionnaire.
"These robust results show Protelos' sustained QoL benefits,
confirming that the treatment maintains its QoL benefits for patients
with vertebral postmenopausal osteoporosis over a four year period.
It is the first anti-osteoporotic treatment to show a QoL benefit for
this patient group", points out SOTI investigator Professor C Roux
from Hôpital Cochin, Paris.
Efficacy across broad range of patients(3)
Bone turnover marker (BTM) levels may influence the antifracture
efficacy of anti-osteoporotic treatments and are therefore taken into
account when deciding to commence treatment. To measure the link
between BTM levels and the efficacy of Protelos, results from both
the SOTI and TROPOS trials were examined.  After three years of
treatment, the risk of new vertebral fractures was significantly
lower in the group taking Protelos than those receiving placebo,
regardless of their BTM levels.
"We found that the efficacy of Protelos to significantly reduce
the incidence of vertebral fractures is largely independent of
pre-treatment bone turnover", said study author Professor J Collette
from the Liège University Hospital, Belgium. "This suggests that
Protelos offers clinical benefits to osteoporotic women across a wide
range of metabolic states and disease severity."
Unique dual mode of action(4,5)
Two further studies presented at the ECTS meeting provide insight
into Protelos' unique mechanism of action. These studies show that
that the new agent promotes either the differentiation of osteocytes,
and/or osteocyte survival which can, at least in part, explain its
ability in vivo to correct the balance between bone resorption and
formation in osteoporosis and that Protelos increases bone formation,
while simultaneously increasing the expression of osteoprotegerin, a
protein that protects against bone loss, reducing bone resorption.
Protelos is licensed in Europe for the treatment of postmenopausal
osteoporosis to reduce the risk of vertebral and hip fractures in
patients with or without a previous history of fractures. It is now
registered in 77 countries worldwide and launched in 44 countries,
including France, Germany, the UK, Spain, and Italy.
References:
(1). JY Reginster, K Brixen, C Cormier, J Cannata. Strontium
ranelate demonstrates vertebral and non-vertebral anti fracture
efficacy including hip fractures over 5 years in post menopausal
osteoporotic women. Poster presentation ECTS 2007.
(2). P. Marquis, C Roux, M Diaz-Curiel, C Cormier G Isaia, J
Badurski, JD Wark. Long-term beneficial effects of strontium ranelate
on the quality of life in patients with vertebral osteoporosis (SOTI
study). Poster presentation ECTS 2007.
(3). J.Collette. Strontium ranelate decreases vertebral fracture
risk whatever the level of pretreatment bone turnover markers. Oral
presentation ECTS 2007.
(4). TC Brennan MS Rybchyn, P Halbout, AD Conigrave, RS Mason,
Strontium ranelate effects in human osteoblasts support its
uncoupling effect on bone formation and bone resorption. Poster
presentation ECTS 2007.
(5). GJ Atkins, KJ Welldon, DM Findlay. Strontium ranelate
promotes an osteocyte-like phenotype from human primary osteoblasts
ex vivo. ECTS poster presentation 2007.

Contact:

For further information or to arrange an interview with Professors
Reginsster and Roux, please contact Matthew Foster, tel:
+44-(0)207-798-9900, email: matthew.foster@toniclc.com or Moira
Gitsham, tel: +33-5-46-00-08-20, email: moira.gitsham@toniclc.com

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