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


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

- 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

© PR Newswire Association LLC.

News archive

Subscribe to AfterDawn's weekly newsletter.