TORONTO, June 1 /CNW/ - Health Canada has approved Actonel(R)
(risedronate sodium tablets) 150 mg, Canada's first and only once-a-month
dosing option in the treatment of postmenopausal osteoporosis. Canadian
patients at high risk of osteoporotic fracture now have the convenience of
taking one tablet on the same day each month.
"Many of my osteoporosis patients have asked me about the availability of
a once-a-month dosing option," said Dr. Rick Adachi, Professor, Department of
Medicine, Michael G. DeGroote School of Medicine, St. Joseph's Healthcare -
McMaster University. "For those women who lead active lifestyles and who want
to simplify their dosing regimen, Actonel 150 mg is an ideal option because it
This new option builds upon the proven vertebral and nonvertebral
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) No other bisphosphonate approved for the treatment of
osteoporosis has been shown in clinical trials to reduce the risk of fractures
earlier than 12 months.(1-6)
"I'm very excited about the new once-a-month option because it will make
my life simpler," said osteoporosis patient Anne Wolf. "I have made a
commitment to take charge of my osteoporosis and this will be a good fit with
Osteoporosis affects almost two million Canadians. "Treating osteoporosis
and the related fractures costs our healthcare system $1.9 billion every year,
not to mention the impact it can have on patients and their families," said
Julie Foley, President and CEO, Osteoporosis Canada. "The approval of a new
once-a-month dosing regimen will be welcome news for many women living with
osteoporosis. It is vital that a range of treatment and dosing options are
available so patients can discuss with their physician the option that best
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
dosing regimen. In addition to Actonel 150 mg Once-a-Month, Actonel is
available in other dosing options (such as 5 mg daily, 35 mg Once-a-Week and
75 mg two consecutive days a month), allowing physicians to help patients
choose the option that best meets their unique needs and lifestyle.
"Patients and health-care providers are at the heart of everything we
do," said Andy McClenaghan, Country Manager, P&G Pharmaceuticals Canada Inc.
"As a leader in osteoporosis, we are pleased to provide Canadian women with
this once-a-month option."
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(14) 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 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).
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(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
(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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