Vienna, Austria (ots/PRNewswire) -
- New Data Demonstrate "Unique", Five Year Anti-Osteoporotic
Efficacy Against Both Vertebral and Non-Vertebral Fractures
New five year data presented at the 6th European Congress on
Clinical and Economic Aspects of Osteoporosis and Osteoarthritis
(ECCEO 6) meeting today show that the new osteoporosis treatment
Protelos(R) (strontium ranelate, Servier) has sustained efficacy
against both vertebral and non-vertebral fractures in postmenopausal
osteoporotic women.(1) In particular, the new data demonstrate a
significant reduction in the risk of new vertebral fracture by up to
a third in patients receiving Protelos compared to those receiving
"These long term results demonstrate that Protelos is unique among
osteoporosis treatments", says lead study investigator Professor J-Y
Reginster from the University of Liège in Belgium. "Protelos is the
first and only anti-osteoporotic treatment to show five-year,
evidence-based efficacy against both vertebral and non-vertebral
fractures and should be considered for sustained first-line therapy
in women with postmenopausal osteoporosis."
These long-term efficacy results are of particular interest when
we know that one-year adherence rates of current therapies, mainly
bisphosphonates, are less than 25%.(2)
Protelos, first approved in the EU in September 2004 to reduce the
risk of vertebral and hip fractures in patients with postmenopausal
osteoporosis, is a novel anti-osteoporotic treatment with an
innovative dual mechanism of action. Unlike other osteoporosis
treatments, Protelos both increases bone formation and decreases bone
resorption.(3) This unique action on bone metabolism allows the
natural process of bone remodelling (bone resorption and bone
formation) to continue in such a way that bone turnover is rebalanced
in favour of the formation of new and stronger bone.
SOTI and TROPOS
In its Phase III drug development programme, two double-blind,
placebo-controlled studies were performed in Caucasian women with
postmenopausal osteoporosis in 75 European and Australian centres -
SOTI (Spinal Osteoporosis Therapeutic Intervention, n= 1649) and
TROPOS (Treatment Of Peripheral Osteoporosis, n=5091).(4,5) The main
analysis of these study results was completed after three years and
demonstrated the efficacy of Protelos at vertebral and non-vertebral
sites and also specifically at the hip level (5). Both studies,
however, were continued for five years to obtain long term efficacy
and safety data.
In SOTI, patients were randomised to receive Protelos 2g per day
or placebo for four years. During a further fifth year, half the
Protelos group received placebo while the other half continued their
active treatment. The long term efficacy data confirmed a significant
reduction in the risk of new vertebral fracture by 33% in the
Protelos group (n=719) as compared to the placebo group (n=723) in
the intention to treat population over four years treatment (relative
risk (RR) = 0.67, p<0.001).
In TROPOS, patients were randomly assigned to receive Protelos 2g
per day or placebo for five years. Protelos was found to be
significantly more efficacious than placebo with a 24% reduction in
vertebral fracture (RR 0.76, p<0.001) and a 15% reduction in
non-vertebral fracture (RR 0.85, p=0.03) in the intention to treat
population (n= 2479 in the Protelos group and n = 2453 in the placebo
Throughout its clinical development programme, Protelos has been
shown to be well tolerated and easy to use for patients.(6)
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
available in 30 countries worldwide, including Germany, the UK,
Spain, Italy, France and Ireland.
Other trade names for Protelos are: Osseor(R), Protos(R),
1. 1. Reginster JY. Strontium ranelate: an antiosteoporotic
treatment demonstrated vertebral and nonvertebral antifracture
efficacy over 5 years in postmenopausal osteoporotic women. Oral
communication, ECCEO 6 2006, Vienna, Austria.
2. 2. McCombs JS, Thiebaud P, McLaughlin-Miley C, Shi J.
Compliance with drug therapies for the treatment and prevention of
osteoporosis. Maturitas 2004;48:217-287.
3. 3. Marie PJ, Ammann P, Boivin G, et al. Mechanisms of action
and therapeutic potential of strontium in bone. Calcif Tissue Int.
4. 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. 5. Reginster JY, Seeman E, De Vernejoul MC, et al. Strontium
ranelate reduces the risk of nonvertebral fractures in
post-menopausal women with osteoporosis: Treatment of Peripheral
Osteoporosis (TROPOS) Study. J Clin Endocrinol Metab. 2005; 90(5).
6. 6. Protelos European Summary of Product Characteristics.
ots Originaltext: Servier
Im Internet recherchierbar: http://www.presseportal.ch
For further information or to arrange an interview with Professor
Reginster, please contact: Moira Gitsham, tel +33-5-46-00-08-20, mob:
+33-6-20-74-01-92 email: firstname.lastname@example.org Kristin O'Leary,
tel +44-207-798-9900, email: email@example.com