Health Canada recently approved Actonel(R) (risedronate sodium tablets) 75 mg, the first and only monthly two-day dosing regimen for the treatment of post-menopausal osteoporosis soon available for use in Canada. With Actonel 75 mg, patients take one 75 mg tablet on two consecutive days each month. This means a less frequent oral dosing option will soon be available to Canadian osteoporosis patients. Such therapies are currently available only in other countries.

“Patients have been asking me for some time about a monthly dosing regimen,” says Dr. Alexandra Papaioannou, Professor of Medicine, McMaster University. “Until now, Canadian osteoporosis patients have had to take their osteoporosis medications weekly or even daily. This new dosing regimen may offer patients a convenient way to treat their osteoporosis and prevent fractures. Actonel 75 mg may be appealing to newly diagnosed osteoporosis patients at risk for fracture or those currently on daily osteoporosis treatment regimens.”Actonel 75 mg builds upon the proven vertebral and nonvertebral fracture protection of Actonel for the treatment of postmenopausal osteoporosis and has an overall safety profile similar to Actonel 5 mg daily(1). Actonel has been shown to reduce the risk of vertebral(2,3) and nonvertebral fractures(2) including those at the hip(4), and has been shown to reduce the risk of fractures as early as six months(5,6,7). Early fracture protection means fewer patients will suffer the potentially devastating effects of a fracture.“This new dosing regimen is a great option for people with osteoporosis,” says osteoporosis patient Anne Wolf. “I don’t like to take medication more often than I have to, so to only have to take one pill two consecutive days a month, while still protecting myself from fractures is very appealing.”“The approval of a new dosing regimen is welcome news for the millions of Canadians who have osteoporosis,” says Julie Foley, President and CEO, Osteoporosis Canada. “Osteoporosis is a debilitating disease that can take a huge toll on those who suffer from it, their families, and our health care system. It’s vital that a range of treatment and dosing options are available so patients can discuss with their physician the option that best suits them.”With this recent approval, Actonel will be available in multiple dosing options (5 mg daily, 35 mg Once-A-Week, and 75 mg monthly two day dosing regimen) which allows physicians to help patients choose the option that best meets their unique needs and lifestyle.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 approximately 1.4 million Canadians suffer from osteoporosis. It affects one in four women 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 post-menopausal 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. Musculoskeletal pain, rarely severe, has been reported as a common adverse event in patients who received ACTONEL for all indications. In PMO and GIO studies with ACTONEL, 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(1). Please refer to Product Monographs(1,14) for full dosing instructions, contraindications and warnings and precautions.The approval of Actonel 75 mg is based on an active-controlled, double-blind clinical trial of 1,229 postmenopausal women with osteoporosis aged 50 years or older with a lumbar spine bone mineral density (LS BMD) T-score less than or equal to -2.5 OR a LS BMD T-score less than or equal to -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 75 mg, taken on two consecutive days a 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.About The Alliance for Better Bone Health—————————————–The Alliance for Better Bone Health was formed by P&G 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.