2007-09-18

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

- 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.

About sanofi-aventis

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).

Forward Looking Statements

For sanofi-aventis: This press release contains forward-lookingstatements as defined in the Private Securities Litigation Reform Actof 1995, as amended. Forward-looking statements are statements thatare not historical facts. These statements include financialprojections and estimates and their underlying assumptions,statements regarding plans, objectives, intentions and expectationswith respect to future events, operations, products and services, andstatements regarding future performance. Forward-looking statementsare generally identified by the words "expects," "anticipates,""believes," "intends," "estimates," "plans" and similar expressions.Although sanofi-aventis' management believes that the expectationsreflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information andstatements are subject to various risks and uncertainties, many ofwhich are difficult to predict and generally beyond the control ofsanofi-aventis, that could cause actual results and developments todiffer materially from those expressed in, or implied or projectedby, the forward-looking information and statements. These risks anduncertainties include those discussed or identified in the publicfilings with the SEC and the AMF made by sanofi-aventis, includingthose listed under "Risk Factors" and "Cautionary Statement RegardingForward-Looking Statements" in sanofi-aventis' annual report on Form20-F for the year ended December 31, 2006. Other than as required byapplicable law, sanofi-aventis does not undertake any obligation toupdate or revise any forward-looking information or statements.

For P&G: All statements, other than statements of historical factincluded in this release, are forward-looking statements, as thatterm is defined in the Private Securities Litigation Reform Act of1995. Such statements are based on financial data, market assumptionsand business plans available only as of the time the statements aremade, which may become out of date or incomplete. We assume noobligation to update any forward-looking statement as a result of newinformation, future events or other factors. Forward-lookingstatements are inherently uncertain, and investors must recognizethat events could differ significantly from our expectations. Inaddition to the risks and uncertainties noted in this release, thereare certain factors that could cause actual results to differmaterially from those anticipated by some of the statements made.These include: (i) the ability to achieve business plans, includingwith respect to lower income consumers and growing existing sales andvolume profitably despite high levels of competitive activity,especially with respect to the product categories and geographicalmarkets (including developing markets) in which the Company haschosen to focus; (ii) the ability to successfully execute, manage andintegrate key acquisitions and mergers, including (a) the Dominationand Profit Transfer Agreement with Wella, and (b) the Company'smerger with The Gillette Company, and to achieve the cost and growthsynergies in accordance with the stated goals of these transactions;(iii) the ability to manage and maintain key customer relationships;(iv) the ability to maintain key manufacturing and supply sources(including sole supplier and plant manufacturing sources); (v) theability to successfully manage regulatory, tax and legal matters(including product liability, patent, and intellectual propertymatters as well as those related to the integration of Gillette andits subsidiaries), and to resolve pending matters within currentestimates; (vi) the ability to successfully implement, achieve andsustain cost improvement plans in manufacturing and overhead areas,including the Company's outsourcing projects; (vii) the ability tosuccessfully manage currency (including currency issues in volatilecountries), debt, interest rate and commodity cost exposures; (viii)the ability to manage continued global political and/or economicuncertainty and disruptions, especially in the Company's significantgeographical markets, as well as any political and/or economicuncertainty and disruptions due to terrorist activities; (ix) theability to successfully manage competitive factors, including prices,promotional incentives and trade terms for products; (x) the abilityto obtain patents and respond to technological advances attained bycompetitors and patents granted to competitors; (xi) the ability tosuccessfully manage increases in the prices of raw materials used tomake the Company's products; (xii) the ability to stay close toconsumers in an era of increased media fragmentation; and (xiii) theability to stay on the leading edge of innovation and maintain apositive reputation on our brands. For additional informationconcerning factors that could cause actual results to materiallydiffer from those projected herein, please refer to our most recent10-K, 10-Q and 8-K reports.

REFERENCES

(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

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Actonel Halves Risk of Fracture in Osteoporotic Women With History of Hip Fracture

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