Actonel Halves Risk of Fracture in Osteoporotic Women With History of Hip Fracture
Honolulu, Hawaii (ots/PRNewswire) - New data show that Actonel(R)5mg (risedronate sodium tablets) reduces the risk of clinicalfractures by half versus placebo over three years in postmenopausalwomen with osteoporosis who have suffered a previous hip fracture(1)-a group of patients at high risk of a subsequent fracture. Theseresults are from a retrospective analysis of the Actonel HIP trial(2)and were presented today at the American Society for Bone and MineralResearch (ASBMR) 29th Annual Meeting.
"As physicians we want assurance that a therapy is effective attreating varying severities of disease. In this analysis risedronateeffectively reduced fracture risk among patients with severeosteoporosis," said Dr Michael McClung, primary investigator of thestudy and founding director of the Oregon Osteoporosis Centre inPortland, Oregon, USA.
A history of prior fracture is an important risk factor for futurefracture. After a postmenopausal woman suffers a hip fracture herrisk is approximately doubled for sustaining another fracture at thehip or elsewhere.(3) Despite this, multiple studies suggest thatelderly adults with hip fractures rarely receive therapy forosteoporosis.(4) In one study, only 13% of hip fracture patientsreceived treatment in the year following the fracture.(5)
"It is troubling that so few patients who have had a hip fracturereceive appropriate care for osteoporosis" said Dr Steven Boonen,medical director of Leuven University Centre for Metabolic BoneDiseases, Belgium. "Therapies are available that can help reduce therisk of subsequent osteoporosis-related fractures. These high riskpatients should be aggressively identified and managed to helpprevent further fractures from occurring."
About the Analysis
Patients were identified from the Actonel HIP trial who werebetween 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 leastone hip fracture prior to the study. The mean age of the patients was75 years and the mean femoral neck and lumbar spine T-scores were-3.1 and -3.2, respectively. These patients were evaluated forcombined incidence of clinical vertebral and nonvertebral fracturesby a time-to-event analysis (Kaplan-Meier). All fractures wereconfirmed by x-ray.
The incidence of osteoporosis-related clinical fractures overthree 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 withActonel.(1)
Notes to Editors:
This study was sponsored by The Alliance for Better Bone Health
- Osteoporosis is a skeletal disease that increases bonefragility and susceptibility to fracture. Fracture is a devastatingconsequence of osteoporosis.
- A 50-year-old woman has around a 40% lifetime risk ofsuffering a fracture from osteoporosis(6) - equivalent to the women'slifetime risk for cardiovascular disease(7)
- Osteoporosis affects an estimated 75 million people inEurope, USA and Japan(8).
- Someone suffers an osteoporosis-related fracture about every30 seconds in Europe alone(9)
- In 2000, the estimated direct costs of osteoporosis-relatedfractures in Europe were EUR31.7 billion - this is expected toincrease to EUR76.7 billion by 2050 based on the expected changes inthe age profile of the European population(10)
Impact of hip fractures in Europe
- Approximately one in five people who suffer a hip fracturewill die within the following year(11),(12)
- The annual number of hip fractures will increase from414,000 in 2000 to 972,000 in 2050(13) - equivalent to nearly two hipfractures every minute, 111 an hour or 2663 a day
- Hip-fracture patients occupy one fifth of all orthopaedicbeds and account for nearly 90% of acute hospital costs ofosteoporosis-related fractures(14)
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & GamblePharmaceuticals and Aventis part of the sanofi-aventis Group, in May1997 to promote bone health and disease awareness through numerousactivities 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 peoplearound The world. The company has one of the strongest portfolios oftrusted, 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 communityconsists of over 135,000 employees working in over 80 countriesworldwide. Please visit http://www.pg.com for the latest news andin-depth information about P&G and its brands.
Sanofi-aventis is the world's third-largest pharmaceuticalcompany, ranking number one in Europe. Backed by a world-class R&Dorganization, sanofi-aventis is developing leading positions in sevenmajor therapeutic areas: cardiovascular, thrombosis, oncology,metabolic diseases, central nervous system, internal medicine, andvaccines. 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 ofclinical fracture among patients with prior hip fracture. ASBMR.2007. Honolulu. Abstract.
(2) McClung MR et al. Effect of risedronate on the risk of hipfracture in elderly women. N Engl J Med 2001;344: 333-340.
(3) Klotzbuecher, CM, et al. Patients with prior fractures have anincreased risk of future fractures: a summary of the literature andstatistical synthesis. J of Bone Min Res 2000;15: 721-739.
(4) Sheryl L.et al. Lack of diagnosis and treatment ofosteoporosis in men and women after hip fracture. Pharmacotherapy2003;23(2): 190-198.
(5) Orwig DL, et al. Treatment of osteoporosis following a hipfracture: sending results of bone densitometry to primary carephysicians does not increase use of pharmacologic therapy (abstr). JBone Miner Res 2001;15(suppl 1): SA323.
(6) Melton LJ et al. Perspective. How many women haveosteoporosis? J Bone Miner Res 1992; 7: 1005-1010
(7) Kanis J A. Diagnosis of osteoporosis and assessment offracture risk. Lancet 2002; 359: 1929-36
(8) EFFO and NOF Who are candidates for prevention and treatmentfor osteoporosis? Osteoporos Int 1997;7:1.
(9) International Osteoporosis Foundation. Osteoporosis in theEuropean Community: a call to action. An audit of policy developmentssince 1998. International Osteoporosis Foundation 2001
(10) Kanis JA, Johnell O. Requirements for DXA for the managementof 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 hipfracture: a population-based study. J Am Geriatr Soc 2002; 50:1644-1650
(12) Magaziner J, Simonsick EM, Kashner TM, et al. Predictors offunctional recovery one year following hospital discharge for hipfracture: a prospective study. J Gerontol 1990; 45: M101-M107
(13) European Commission Report on Osteoporosis in the EuropeanCommunity. Action for prevention. Luxembourg: Office for OfficialPublications of the European Communities 1998
(14) World Health Organisation. Prevention and management ofosteoporosis. WHO Technical Report Series 921. Geneva: World HealthOrganisation 2003.
For further information please contact: Helen Crow Ketchum +44-(0)7787-533-023 Peter Impey Ketchum +44-(0)7976-734-493
ots Originaltext: Alliance for Better Bone HealthIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Helen Crow, Ketchum, +44-(0)7787-533-023; Peter Impey, Ketchum, +44-(0)7976-734-493
Alliance for Better Bone Health
In Zusammenarbeit mit Medizinfuchs
Actonel Halves Risk of Fracture in Osteoporotic Women With History of Hip Fracture