HONOLULU, Hawaii, September 18 /PRNewswire/ -- New data show that Actonel(R) 5mg (risedronate sodium tablets) reduces the risk of clinical fractures by half versus placebo over three years in postmenopausal women with osteoporosis who have suffered a previous hip fracture(1)- a group of patients at high risk of a subsequent fracture. These results are from a retrospective analysis of the Actonel HIP trial(2) and were presented today at the American Society for Bone and Mineral Research (ASBMR) 29th Annual Meeting.
"As physicians we want assurance that a therapy is effective at treating varying severities of disease. In this analysis risedronate effectively reduced fracture risk among patients with severe osteoporosis," said Dr Michael McClung, primary investigator of the study and founding director of the Oregon Osteoporosis Centre in Portland, Oregon, USA.
A history of prior fracture is an important risk factor for future fracture. After a postmenopausal woman suffers a hip fracture her risk is approximately doubled for sustaining another fracture at the hip or elsewhere.(3) Despite this, multiple studies suggest that elderly adults with hip fractures rarely receive therapy for osteoporosis.(4) In one study, only 13% of hip fracture patients received treatment in the year following the fracture.(5)
"It is troubling that so few patients who have had a hip fracture receive appropriate care for osteoporosis" said Dr Steven Boonen, medical director of Leuven University Centre for Metabolic Bone Diseases, Belgium. "Therapies are available that can help reduce the risk of subsequent osteoporosis-related fractures. These high risk patients should be aggressively identified and managed to help prevent further fractures from occurring."
About the Analysis
Patients were identified from the Actonel HIP trial who were between the ages of 70-79 years, had low bone mineral density (BMD, T-score lesser than or equal to -2.5), and had a history of at least one hip fracture prior to the study. The mean age of the patients was 75 years and the mean femoral neck and lumbar spine T-scores were -3.1 and -3.2, respectively. These patients were evaluated for combined incidence of clinical vertebral and nonvertebral fractures by a time-to-event analysis (Kaplan-Meier). All fractures were confirmed by x-ray.
The incidence of osteoporosis-related clinical fractures over three years among patients taking Actonel 5mg versus placebo was 13% (12 of 106 patients) and 28.4% (27 of 111 patients), respectively, corresponding to a 50% reduction (p=0.048) in fracture risk with Actonel.(1)
Notes to Editors:
This study was sponsored by The Alliance for Better Bone Health
- Osteoporosis is a skeletal disease that increases bone fragility and susceptibility to fracture. Fracture is a devastating consequence of osteoporosis.
- A 50-year-old woman has around a 40% lifetime risk of suffering a fracture from osteoporosis(6) - equivalent to the women's lifetime risk for cardiovascular disease(7)
- Osteoporosis affects an estimated 75 million people in Europe, USA and Japan(8).
- Someone suffers an osteoporosis-related fracture about every 30 seconds in Europe alone(9)
- In 2000, the estimated direct costs of osteoporosis-related fractures in Europe were EUR31.7 billion - this is expected to increase to EUR76.7 billion by 2050 based on the expected changes in the age profile of the European population(10)
Impact of hip fractures in Europe
- Approximately one in five people who suffer a hip fracture will die within the following year(11),(12)
- The annual number of hip fractures will increase from 414,000 in 2000 to 972,000 in 2050(13) - equivalent to nearly two hip fractures every minute, 111 an hour or 2663 a day
- Hip-fracture patients occupy one fifth of all orthopaedic beds and account for nearly 90% of acute hospital costs of osteoporosis-related fractures(14)
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble Pharmaceuticals and Aventis part of the sanofi-aventis Group, in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble (NYSE:PG)
Three billion times a day, P&G brands touch the lives of people around The world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R), Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella, Gillette(R), and Braun. The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Sanofi-aventis is the world's third-largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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(1) McClung MR et al. The Effect of risedronate on risk of clinical fracture among patients with prior hip fracture. ASBMR. 2007. Honolulu. Abstract.
(2) McClung MR et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344: 333-340.
(3) Klotzbuecher, CM, et al. Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J of Bone Min Res 2000;15: 721-739.
(4) Sheryl L.et al. Lack of diagnosis and treatment of osteoporosis in men and women after hip fracture. Pharmacotherapy 2003;23(2): 190-198.
(5) Orwig DL, et al. Treatment of osteoporosis following a hip fracture: sending results of bone densitometry to primary care physicians does not increase use of pharmacologic therapy (abstr). J Bone Miner Res 2001;15(suppl 1): SA323.
(6) Melton LJ et al. Perspective. How many women have osteoporosis? J Bone Miner Res 1992; 7: 1005-1010
(7) Kanis J A. Diagnosis of osteoporosis and assessment of fracture risk. Lancet 2002; 359: 1929-36
(8) EFFO and NOF Who are candidates for prevention and treatment for osteoporosis? Osteoporos Int 1997;7:1.
(9) International Osteoporosis Foundation. Osteoporosis in the European Community: a call to action. An audit of policy developments since 1998. International Osteoporosis Foundation 2001
(10) Kanis JA, Johnell O. Requirements for DXA for the management of osteoporosis in Europe. Osteoporosis Int 2005;16: 229-38
(11) 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
(12) 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
(13) European Commission Report on Osteoporosis in the European Community. Action for prevention. Luxembourg: Office for Official Publications of the European Communities 1998
(14) World Health Organisation. Prevention and management of osteoporosis. WHO Technical Report Series 921. Geneva: World Health Organisation 2003.
For further information please contact: Helen Crow Ketchum +44-(0)7787-533-023 Peter Impey Ketchum +44-(0)7976-734-493
For further information please contact: Helen Crow, Ketchum, +44-(0)7787-533-023; Peter Impey, Ketchum, +44-(0)7976-734-493