TORONTO, June 24 /CNW/ - Ontario patients at high risk of osteoporotic
fracture now have access to Actonel 150 mg Once-a-Month now that the Ontario
government has recommended the listing of this new formulation on their
publicly-funded drug plan. This new listing will take effect on June 23, 2009.
Actonel 150mg Once-a-Month builds upon the proven fracture protection of
Actonel for the treatment of postmenopausal osteoporosis, with an overall
safety and tolerability profile that is similar to Actonel 5 mg daily. Actonel
has been shown to reduce the risk of vertebral(1),(2) and nonvertebral
fractures(2), including those at the hip,(3) and has been shown to reduce the
risk of fractures as early as six months.(4),(5),(6)
Research(7) has shown that many osteoporosis patients would prefer
monthly oral dosing regimens over other dosing options. The new Actonel 150 mg
may be an attractive option for physicians looking for fracture protection in
a therapy that also provides patients with the convenience of a once-a-month
"Osteoporosis affects almost two million Canadians. Treating osteoporosis
and the related fractures costs our healthcare system billions of dollars
every year, not to mention the impact it can have on patients and their
families" said Andy McClenaghan, Country Manager, P&G Pharmaceuticals Canada
Inc. speaking on behalf of the Alliance for Better Bone Health.
With this listing decision, postmenopausal osteoporosis patients in
Ontario now have access to the convenience of a new once-a-month dosing option
with the proven fracture protection of Actonel.
Osteoporosis is a skeletal disorder characterized by compromised bone
strength predisposing a person to an increased risk of fracture. Bone strength
reflects the integration of two main features; bone density and bone
quality.(8) Osteoporosis Canada reports almost two million Canadians suffer
from osteoporosis. It affects one in four women and at least one in eight men
over the age of 50.(9) Osteoporosis has important public health and clinical
consequences because it leads to fractures that commonly occur at the spine,
wrist or hip. Fractures can result in increased pain, disability, and
A 50-year old woman has a 40 per cent chance of developing hip, vertebra
or wrist fractures during her lifetime.(10) The lifetime risk of hip fracture
is greater (one in six) than the one in nine lifetime risk of developing
breast cancer.(11) Patients are at highest risk for subsequent fracture in the
first few months following a vertebral fracture.(12) One in four women who
have a new vertebral fracture will fracture again within one year.(13)
Actonel (risedronate sodium) is indicated for the treatment and
prevention of osteoporosis in postmenopausal women (PMO), for the treatment of
osteoporosis in men to improve bone mineral density, for Paget's disease, and
for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO)
in men and women. In postmarketing reporting, osteonecrosis of the jaw has
been reported in patients treated with bisphosphonates. Clinical judgement
based on individual risk assessment should guide the management of patients
undergoing dental procedures. Musculoskeletal pain, rarely severe, has been
reported as a common adverse event for all Actonel indications. In PMO and GIO
studies the most commonly reported adverse reactions were abdominal pain,
dyspepsia and nausea. In patients with Paget's disease, diarrhea and headache
were also commonly reported.(14) Please refer to Product Monograph for full
dosing instructions, contraindications, warnings and precautions.
The approval of Actonel 150 mg once-a-month is based on an
active-controlled, double-blind clinical trial of 1,292 postmenopausal women
with osteoporosis aged 50 years or older with a lumbar spine bone mineral
density (LS BMD) T-score (less than) -2.5 OR a LS BMD T-score (less than) -2.0
and at least one prevalent vertebral fracture. In the trial, increases in bone
mineral density (BMD) at the lumbar spine, total hip, and hip trochanter in
patients treated with Actonel 150 mg on the same calendar day each month, were
similar to those in patients treated with Actonel 5 mg daily at both time
points measured (six and 12 months). Both treatments were generally well
tolerated with adverse events between the two groups being similar.(14)
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed in May 1997 to promote
bone health and disease awareness through numerous activities to support
physicians and patients around the globe. It is collaboration between P&G
Pharmaceuticals and sanofi-aventis.
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), Always(R),
Pantene(R), Mach3(R). Bounty(R), Pringles(R), Swiffer(R), Folgers(R),
Charmin(R), Downy(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R),
Olay(R), Clairol Nice 'n Easy(R), Herbal Essences(R), Head & Shoulders(R),
Gillette(R), and Braun. The P&G community consists of almost 140,000 employees
working in over 80 countries worldwide. P&G is the leading consumer products
company in Canada with over $2.7 billion in annual sales. P&G Pharmaceuticals
is a division of P&G Health Care with products such as Actonel(R),
Didrocal(R), Asacol(R), and MacroBID(R).
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
Sanofi-aventis is represented in Canada by the pharmaceutical company
sanofi-aventis Canada Inc., based in Laval, Quebec, and by the vaccines
company Sanofi Pasteur Limited, based in Toronto. Ontario. Together they
employ more than 2,000 people across the country.
(1) Harris ST, Watts NB, Genant HK et al. Effects of risedronate
treatment on vertebral and nonvertebral fractures in women with
postmenopausal osteoporosis. JAMA 1999;282(14):1344-52.
(2) Reginster J-Y et al. Randomized trial of the effects risedronate on
vertebral fractures in women with established postmenopausal
osteoporosis. Osteop Int 2000;11:83-91.7
(3) McClung, M.R., Geusens, P., Miller, P.D., Zippel, H., Bensen, W.G.,
Roux, C., et al. Effect of risedronate on the risk of hip fracture
in elderly women. N Engl J Med. 2001;344:333-40.
(4) Harrington JT, Ste-Marie LG, Brandi ML, et al. Risedronate rapidly
reduces the risk for nonvertebral fractures in women with
postmenopausal osteoporosis. Calcif Tissue Int 2004;74:129-135.
(5) Roux C, Seeman E, Eastell R, Adachi J, Jackson RD, Felsenberg D,
Songcharoen S, Rizzoli R, Di Munno O, Horlait S, Valent D, Watts NB.
Efficacy of risedronate on clinical vertebral fractures within six
months. Curr Med Res Opinion 2004; 20(4): 433-439.
(6) Silverman SL, Watts NB, Delmas PD, Lange JL, Lindsay R.
Effectiveness of bisphosphonates on nonvertebral and hip fractures
in the first year of therapy: the risedronate and alendronate (REAL)
cohort study. Osteoporos Int 2007; 18(1): 25-34.
(7) Simon J, Beusterien K, Hebborn A, Leidy N. Bisphosphonate dosing
preferences in women with postmenopausal osteoporosis: A Study. The
Female Patient. July 2005. Vol 30:31-36.
(8) Osteoporosis prevention, diagnosis and therapy. NIH consensus
(9) Hanley DA, Josse RG. Prevention and management of osteoporosis:
consensus statements from the Scientific Advisory Board of the
Osteoporosis Society of Canada: 1. Introduction. CMAJ 1996;155:921-
(10) Melton LJ III, Chrischilles EA, Cooper C, Lane AW, Riggs BL.
Perspective: how many women have osteoporosis? J Bone Miner Res
(11) Cummings SR, Black DM, Rubin SM. Lifetime risks of hip, colles', or
vertebral fracture and coronary heart disease among white
postmenopausal women. Arch Intern Med 1989;149:2445-8.
(12) Johnell O, Oden A, Caulin F, Kanis JA. Acute and long-term increase
in fracture risk after hospitalization for vertebral fracture.
Osteoporos Int. 2001;12(3):207-14.
(13) Lindsay R, Burge RT, Strauss DM. One year outcomes and costs
following a vertebral fracture. Osteoporosis Int. 2005; 16:78-85.
(14) Procter & Gamble Pharmaceuticals Canada Inc. ACTONEL Product
Monograph, Toronto, September 17, 2008
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