ROME, June 19, 2010 /PRNewswire/ -- /OFF HOLD OFF HOLD OFF HOLD -- 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
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[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
For further information, please contact: Monica Gounaropoulos, Tonic Life Communications - +44-207-798-9910, monica.g@toniclc.com or Natalie Fairbank, Tonic Life Communications - +44-207-798-9938 natalie.fairbank@toniclc.com .
