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Rome, June 19, 2010 (ots/PRNewswire)

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Servier, PIV395527  The following release: "Protelos(R) (Strontium
Ranelate) Builds Stronger  Bone Compared to Bisphosphonates" is now
OFF HOLD.  Distribution time: 19  Jun 2010 08:15 GMT
The osteoporosis treatment Protelos(R) (strontium ranelate,
Servier) has greater effects than the commonly prescribed
bisphosphonate alendronate on bone microarchitecture (cortical
thickness, trabecular and cortical density) in postmenopausal women
according to a two-year study presented today at the European
Congress of Rheumatology (EULAR) in Rome.[1]
Results of this head-to-head study of 88 women show that,
according to bone scans (HR-pQCT technology), cortical thickness
(p<0.05), trabecular bone fraction (p<0.05), trabecular and cortical
bone densities (p<0.05), increased significantly more in women
treated with Protelos, compared to those treated with the
bisphosphonate. This effect is significant within three months of
treatment. These new results reinforce the recently published,
one-year results of the same study and even demonstrate that the
effect on bone in favour of Protelos increases with time.[2]
"From these results, strontium ranelate appears to have a greater
effect than the bisphosphonate alendronate on tibia bone
microstructure after two years of treatment. Improving bone
microarchitecture reduces the risk of fractures, as there is a strong
association between improving the structure of bone and fracture risk
reduction," points out Professor Rene Rizzoli, Chairman of the
Division of Bone Diseases at the University Hospital, Geneva,
Switzerland and President of The Foundation for Research in
Osteoporosis and Bone Disease.
The link between bone structure and fractures
There is a strong link between bone micro-architecture, a
component of bone quality and hence bone strength, and fracture risk
reduction.
Postmenopausal women have been found to have significantly lower
bone density, trabecular number and cortical thickness than
premenopausal women at both the radius and tibia. In addition,
although spine and hip bone mineral density have been found to be
similar in osteopenic women with or without fractures, fractured
women have lower trabecular density and more heterogeneous trabecular
distribution at the radius compared to women with no fractures.[3]
Protelos, the only antiosteoporotic agent that rebalances bone
turnover in favour of bone formation, improves the bone
microarchitecture, in particular cortical thickness. These
improvements lead to increased bone strength that contributes in high
and sustained anti-fracture efficacy.
Unrivalled proof of efficacy against fractures
Protelos has been shown to be well-tolerated and easy-to-use for
patients.[4] Protelos' antifracture efficacy was highlighted in the
European osteoporosis diagnosis and treatment guidance. This guidance
shows that Protelos has a broader range of efficacy compared to the
other anti-osteoporotic agents and it has been proven to be effective
in treating fractures at vertebral, non-vertebral and hip sites.[5] A
recent assessment of currently available osteoporosis treatments
studied the number of patients needed to treat over a fixed time to
prevent one fracture (NNT). Clearly, the lower the number, the more
efficacious the osteoporosis treatment in the population studied. The
analysis found that Protelos (2g / day) has a very low NNT among the
different osteoporosis treatments studied for the prevention of both
vertebral and hip fracture.[6] Only 9 patients would need to be
treated for 3 years with Protelos in order to prevent a new vertebral
fracture. Furthermore, Protelos has been shown to provide efficacy
against fractures independent of baseline risk factors such as age,
bone mineral density, prevalent fractures and a family history of
osteoporosis.[7] The anti-fracture efficacy has also been shown to be
sustained over eight years, making it the treatment with such unique
proof of long term antifracture efficacy. Long term efficacy is an
important consideration in treatment choice given the question marks
over the long term safety of other treatments.[8]
Notes to editors
Osteoporosis - a common, debilitating disease
Osteoporosis is a chronic condition due to decreased bone mass,
leading to reduced bone strength and fracture risk. Because women are
particularly susceptible to bone loss after the menopause, by far the
most common form is postmenopausal osteoporosis. The estimated
lifetime risk of wrist, vertebral or hip fracture in Caucasian women
over 50 is 45%. The annual incidence rate of osteoporotic fractures
in women is greater than the combined incidence rates of heart
attack, stroke and breast cancer.[9] Postmenopausal osteoporosis has
a huge impact on healthcare budgets, which are already expected to
double for osteoporosis by the year 2050.
Protelos is marketed by independent French pharmaceutical
company, Servier. It is licensed for the treatment of postmenopausal
osteoporosis to reduce the risk of vertebral and hip fractures. It is
currently registered worldwide and launched in 72 countries.
Protelos is also sold under the trade names Protos(R), Osseor(R),
Bivalos(R) and Protaxos(R).
    References
    [1] Rizzoli R, Felsenberg D, Laroche M et al. Superiority of strontium
        ranelate as compared to alendronate on microstructural determinants
        of bone strength at the distal tibia in women with postmenopausal
        osteoporosis. Abstract presented at EULAR Congress 2010.
    [2] Rizzoli R, Laroche M, Krieg MA, et al. Rheumatol Int. 2010 May 29.
        [Epub ahead of print]
    [3] Boutroy S et al. In vivo assessment of trabecular bone
        microachitecture by high-resolution peripheral quantitative computed
        tomography. J Clin Endocrinol Metab 2005;90(12):6508-6515
    [4] Protelos European Summary of Product Characteristics.
    [5] Kanis JA, Burlet B, Cooper C et al. European guidance for
        the diagnosis and management of osteoporosis in post menopausal
        women. Osteoporosis International 2008; 19(4):399-428.
    [6] Ringe JD, Doherty JG. Absolute risk reduction in osteoporosis:
        assessing treatment efficacy by number needed to treat. 2010;30: Epub
        ahead of print
    [7] Roux C, Reginster JY, Fechtenbaum J et al. Vertebral fracture risk
        reduction with strontium ranelate in women with postmenopausal
        osteoporosis is independent of baseline risk factors. J Bone Miner
        Res. 2006;21:536-542.
    [8] Reginster JY, Sawicki A, Roces - Varela A. Strontium ranelate: 8
        years efficacy on vertebral and nonvertebral fractures in post
        menopausal osteoporotic women. Osteoporos Int. 2008;19(Suppl.1):
        S131-S132 (Abstract P311)
    [9] Riggs BL and Melton LJ, 1995, Bone 17(S5):505S; From American Heart
        Association, Heart & Stroke Facts 1996; From American Cancer Society,
        Cancer Facts & Figures, 1996

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CONTACT: For further information, please contact: Monica
Gounaropoulos,Tonic Life Communications - +44-207-798-9910,
monica.g@toniclc.com orNatalie Fairbank, Tonic Life Communications -
+44-207-798-9938natalie.fairbank@toniclc.com .

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