Health Canada approves new dosing option for Actonel

June 2009 

Health Canada has approved a 150mg dosing option for Actonel ® (risedronate sodium tablets), making it the only once-a-month dosing option in Canada for the treatment of postmenopausal osteoporosis. 

“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 is convenient.”

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 vertebral1,2 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 my lifestyle.”

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 suits them.”

Research7 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. Actonel is also 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.”

About Osteoporosis

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 mortality.  

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

About Actonel

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.

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 < -2.5 OR a LS BMD T-score < -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

Note: Effective June 23rd, 2009, Actonel® 150 mg Once-a-Month will be reimbursed as a General Benefit on the Ontario Drug Benefit Formulary (ODBF). This means physicians and their osteoporosis patients at high risk of fracture who qualify for ODB coverage (patients 65 years of age and older, those receiving social assistance, and those in certain special circumstances such as residents of long-term care) have full, unlimited access to Actonel 150 mg Once-a-Month.

References

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 statements 2000;17(1):1-45.
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;155:921-3.
10 Melton LJ III, Chrischilles EA, Cooper C, Lane AW, Riggs BL. Perspective: how many women have
osteoporosis? J Bone Miner Res 1992;7:1005-10.
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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