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18.09.2007 – 08:24

Alliance for Better Bone Health

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 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
  • 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.
About sanofi-aventis
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).
Forward Looking Statements
For sanofi-aventis: This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform Act
of 1995, as amended. Forward-looking statements are statements that
are not historical facts. These statements include financial
projections and estimates and their underlying assumptions,
statements regarding plans, objectives, intentions and expectations
with respect to future events, operations, products and services, and
statements regarding future performance. Forward-looking statements
are generally identified by the words "expects," "anticipates,"
"believes," "intends," "estimates," "plans" and similar expressions.
Although sanofi-aventis' management believes that the expectations
reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of
which are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. These risks and
uncertainties include those discussed or identified in the public
filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form
20-F for the year ended December 31, 2006. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
For P&G: All statements, other than statements of historical fact
included in this release, are forward-looking statements, as that
term is defined in the Private Securities Litigation Reform Act of
1995. Such statements are based on financial data, market assumptions
and business plans available only as of the time the statements are
made, which may become out of date or incomplete. We assume no
obligation to update any forward-looking statement as a result of new
information, future events or other factors. Forward-looking
statements are inherently uncertain, and investors must recognize
that events could differ significantly from our expectations. In
addition to the risks and uncertainties noted in this release, there
are certain factors that could cause actual results to differ
materially from those anticipated by some of the statements made.
These include: (i) the ability to achieve business plans, including
with respect to lower income consumers and growing existing sales and
volume profitably despite high levels of competitive activity,
especially with respect to the product categories and geographical
markets (including developing markets) in which the Company has
chosen to focus; (ii) the ability to successfully execute, manage and
integrate key acquisitions and mergers, including (a) the Domination
and Profit Transfer Agreement with Wella, and (b) the Company's
merger with The Gillette Company, and to achieve the cost and growth
synergies 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) the
ability to successfully manage regulatory, tax and legal matters
(including product liability, patent, and intellectual property
matters as well as those related to the integration of Gillette and
its subsidiaries), and to resolve pending matters within current
estimates; (vi) the ability to successfully implement, achieve and
sustain cost improvement plans in manufacturing and overhead areas,
including the Company's outsourcing projects; (vii) the ability to
successfully manage currency (including currency issues in volatile
countries), debt, interest rate and commodity cost exposures; (viii)
the ability to manage continued global political and/or economic
uncertainty and disruptions, especially in the Company's significant
geographical markets, as well as any political and/or economic
uncertainty and disruptions due to terrorist activities; (ix) the
ability to successfully manage competitive factors, including prices,
promotional incentives and trade terms for products; (x) the ability
to obtain patents and respond to technological advances attained by
competitors and patents granted to competitors; (xi) the ability to
successfully manage increases in the prices of raw materials used to
make the Company's products; (xii) the ability to stay close to
consumers in an era of increased media fragmentation; and (xiii) the
ability to stay on the leading edge of innovation and maintain a
positive reputation on our brands. For additional information
concerning factors that could cause actual results to materially
differ from those projected herein, please refer to our most recent
10-K, 10-Q and 8-K reports.
REFERENCES
(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

Contact:

For further information please contact: Helen Crow, Ketchum,
+44-(0)7787-533-023; Peter Impey, Ketchum, +44-(0)7976-734-493