Paris [Friday 17 November 2006] -- Data published today from a retrospective study of over 33,000 postmenopausal women showed that among patients newly prescribed one of the two most popular osteoporosis treatments, patients taking Actonel (risedronate sodium) were approximately half as likely to sustain a hip fracture as those taking alendronate in the first year of treatment. These results were published today in the peer-reviewed journal Osteoporosis International.1
"The rapid onset of fracture reduction observed for risedronate in this study is consistent with results from randomised clinical trials of risedronate," says Professor Pierre Delmas, study author, Universite Claude Bernard, Lyon. "Earlier fracture protection means that fewer patients will suffer the devastating consequences of an osteoporotic fracture, helping to both preserve patients' quality of life and to reduce the economic burden of healthcare.'
The REAL (RisedronatE, ALendronate) retrospective cohort study included 33,830 women newly treated with once-weekly doses of either Actonel or alendronate in 'real-life' clinical practice. Results showed that at six months patients on Actonel had a 46% (p=0.02) lower incidence of hip fractures compared to patients on alendronate. At 12 months similar results were seen, with Actonel resulting in a 43% (p=0.01) greater reduction in risk of hip fracture versus alendronate. The two treatments were not compared on the basis of side effects in this study.
This study adds to the body of evidence from randomised controlled trials demonstrating that Actonel exerts an early onset of fracture protection, seen as early as six months for clinical vertebral fracture and nonvertebral fractures.2-3 No other bisphosphonate treatments for osteoporosis have been shown in clinical trials to reduce clinical fractures this early for patients. However, data are limited that compare therapies directly in the same study on the basis of fracture reduction - the clinically important endpoint in osteoporosis treatment.
"In the osteoporosis field it is unlikely that prospective, head-to-head clinical fracture trials will be conducted due to the large number of patients required to show a difference between two effective therapies," said Professor Delmas. "Large, comparative, retrospective analyses, like the REAL study, are one way to fill the knowledge gap and should be considered in the total body of evidence for a drug to optimise treatment decisions and enhance patient care."
Currently 1.6 million hip fractures occur worldwide per year,4 accounting for approximately 104 billion Euros in worldwide annual healthcare costs.5 Among those patients who suffer a hip fracture, approximately one in five will die within the following year,6,7 and 40% will be unable to walk independently one year later.8
- Silverman S, et al. Effectiveness of bisphosphonates on non-vertebral and hip fractures in the first year of therapy, the risedronate and alendronate cohort study. Osteoporosis Int 2006
- Roux C, Seeman E., Eastell R., Adachi J, Jackson RD, Felsenberg D, Songcharoen S, Rozzoli R, Di Munno O, Horlait S, Valent D, watts NB, Efficacy of risedronate on clinical vertebral fractures within six months. Curr Med Res Opin. 2004;20(4):433-9
- Harrington JT, Ste-Marie LG, Brandi ML, Civitelli R, Fardellone P, Grauer A, Barton I, Boonen S. Risedronate rapidly reduces the risk for nonvertebral fractures in women with postmenopausal osteoporosis. Calcif Tissue Int. 2004; 74: 129-135 .
- International Osteoporosis Foundation. Facts and statistics about osteoporosis and its impact. Last accessed 7th November 2006
- Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med 1997; 103: 20S-26
- Cooper C, Atkinson EJ, Jacobsen SJ, et al. Population-based study of survival after osteoporotic fractures. Am J Epidemiol 1993 ; 137: 1001-1005
- Leibson CL, Tosteson AN, Gabriel SE, et al. Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J Am Geriatr Soc 2002; 50: 1644-1650
- Magaziner J, Simonsick EM, Kashner TM, et al. Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol 1990; 45: M101-M107
- Melton LJ et al. Perspective. How many women have osteoporosis? J Bone Miner Res 1992; 7: 1005-1010
- Kanis J A. Diagnosis of osteoporosis and assessment of fracture risk. Lancet 2002; 359: 1929-36