Protelos(R) (strontium Ranelate) Is The First Osteoporosis Treatment To Demonstrate Long-term Reduced Risk Of Hip Fracture

Main Category: Bones / Orthopaedics
Article Date: 11 Jul 2008 - 1:00 PST

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Results of a new study published in the latest edition of leading journal Arthritis and Rheumatism confirm a long-term reduction in the risk of fractures with strontium ranelate in post menopausal women with osteoporosis. The trial, which studied the efficacy of strontium ranelate over a five year period, showed significant reductions of up to 43% (p<0.036) in the risk of hip fractures, the fracture type most associated with increases in mortality and morbidity in post menopausal women.1 No other treatment for postmenopausal osteoporosis has demonstrated such long-term reductions.

TROPOS (TReatment Of Peripheral OSteoporosis), a randomised, double-blind placebo controlled trial, was designed to investigate the long-term efficacy of strontium ranelate in reducing the risk of non-vertebral fractures in postmenopausal osteoporosis. Performed in 75 centres across Australia and Europe, 5,091 women took part in the study, of which 2,714 (53%) completed the full five year duration.1

Analysis of the data has shown that those patients randomised to receive strontium ranelate (2g/day) had a 43% reduction in the risk of hip fractures, a 24% decrease in vertebral fractures, and a 15% reduction in non-vertebral fractures, compared to those who received placebo for 5 years. The safety profile of strontium ranelate over the five year period remained unchanged compared to previous data over three years. The drug was well tolerated with no new adverse events reported. 1

Commenting on the results, Professor Tim Spector of St Thomas' Hospital, London said, "Osteoporosis treatment is long-term and yet there are few long-term randomised trials. It is therefore encouraging to see data demonstrating clear fracture prevention over five years. These results will improve our confidence further in our ability to improve long-term quality of life in our patients."

The body of evidence showing long-term effects of strontium ranelate is further supported by the recent presentation of data demonstrating increases in Bone Mineral Density (BMD), over eight years. Data from patients in the 3-year extensions to the TROPOS and Spinal Osteoporosis Therapeutic Intervention (SOTI) studies, demonstrated year on year increases in BMD at both lumbar and femoral neck sites. At the same time, there was no significant difference in the incidence of fractures during the extension phase, compared to the first three years of the study, which is an indicator that despite an increase in fracture risk associated with age, strontium ranelate remained effective at reducing fracture risk over the full eight year period.2

Osteoporosis is a progressive bone disease characterised by a loss of bone density and deterioration of the bone structure, which results in increased bone fragility and susceptibility to fracture. At least one in two adult women aged 50 and over will sustain one vertebral, hip or other fractures 3, at an estimated cost to the NHS of between £1.5 and £1.8 billion per year. 4 Broken bones can be painful and cause other problems, and getting back to full mobility and independence can be difficult.

Strontium ranelate has recently been approved for the management of primary and secondary prevention of postmenopausal osteoporosis by the National Institute for Health and Clinical Excellence (NICE).

- Protelos is an anti-osteoporotic treatment with a unique mode of action; simultaneously increasing bone formation markers whilst decreasing bone resorption markers. Launched in 2004, Protelos is licensed for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. Protelos is administered as a 2g sachet of powder to be suspended in a glass of water, which should be taken once daily, preferably at bedtime, and at least two hours after eating. 5

- Servier Laboratories Limited is the British subsidiary of the Servier Research Group, a leading French based organisation specialising in ethical pharmaceuticals.

- Servier's product portfolio in the UK focuses on the therapeutic areas of osteoporosis, cardiovascular disease and diabetes. Servier's R&D pipeline is extremely healthy having the potential to submit one product for license every year for the next 8 to 10 years.

References:

1. J.Y. Reginster et al. Effects of long-term strontium renelate treatment on the risk of non-vertebral and vertebral fractures in postmenopausal osteoporosis: results of 5-year randomized placebo-controlled trial. Arthritis and Rheumatism 2008;58(6):1687-95

2. J.Y. Reginster et al. Strontium ranelate: 8 years efficacy on vertebral and nonvertebral fractures in post menopausal osteoporotic women. Presented at the European Congress on Clinical and Economic aspects of Osteoporosis (ECCEO), April 2008.

3. National Osteoporosis Society website. What is Osteoporosis? Available at: http://www.nos.org.uk Date last accessed 4 June 2008

4. Clinical answers website. What are the cost implications for the NHS for someone who has a fracture due to osteoporosis? Available at: http://www.clinicalanswers.nhs.uk Date last accessed 23 June 2008

5. Protelos® Summary of Product Characteristics 23 January 2008

http://www.servier.co.uk