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

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

May 07, 2007

    -- New Data Show Clear Benefit of Protelos(R) in Wide
Range of
Osteoporosis Patients Irrespective of Disease Severity

    COPENHAGEN, Denmark, May 7 /Xinhua-PRNewswire/ -- 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 Hopital 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 Liege 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 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.


    For more information, please contact: 

    Matthew Foster
    Tel:   [phone]
    Email: [e-mail]

    Moira Gitsham
    Tel:   [phone]
    Email: [e-mail]