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Ketchum
Osteoporosis treatment now approved in Europe and US for men
Male osteoporosis: Neglected and undertreated
Paris, August 17, 2006 – The US Food and Drug Administration (FDA) this week approved Actonel® 35mg (risedronate sodium tablets) for 'treatment to increase
bone mass in men with osteoporosis'. This follows the positive outcome in July 2006 of the European application for the additional indication of 'treatment of osteoporosis in men at high risk of
fracture'. National approvals will now follow in all twenty-five EU member states. This new indication now opens the door for more men with osteoporosis to benefit from Actonel treatment.
"Male osteoporosis is neglected and under-treated," said Pierre Delmas, Professor of Medicine and Rheumatology at the Université Claude Bernard, in Lyon, France.
"We have to ask ourselves why other conditions such as prostate cancer receive more attention than osteoporosis, when in reality men over 50 are at far greater risk of osteoporosis than they are of
prostate cancer. We cannot accept the low levels of awareness that exist among patients and physicians because osteoporosis is such a devastating and debilitating disease for men."
Approximately half of male osteoporosis cases are associated with aging. Men with age-related osteoporosis usually develop the disease later in life than do women. With an
aging population and increasing life expectancy, age-related cases of male osteoporosis are expected to increase. The other half of all male osteoporosis cases are due to secondary causes such as oral
steroid use, low testosterone (hypogonadism), and heavy alcohol use. (1)
The approval of Actonel for men with osteoporosis is based on a two-year, placebo-controlled, double-blind multi-centre clinical trial of 284 male patients with
osteoporosis. (2) In the trial, patients treated with once-a-week Actonel 35mg experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured, 6, 12
and 24 months. Likewise, statistically significant reductions in bone turnover markers were achieved at all time points measured, 3, 6, 12 and 24 months. Actonel was well-tolerated and adverse events
were generally similar between patients receiving Actonel and patients receiving placebo. The most commonly reported adverse events were constipation, back pain, arthralgia, influenza and
nasopharyngitis.
"This approval builds upon the efficacy of Actonel seen in women," said David Cahall, International Medical Director, sanofi-aventis. "With this new
indication we hope many men, a group of patients that are often overlooked, will now be able to benefit from treatment with Actonel".
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