The FDA ( Food and Drug Administration ) has approved Actonel 35mg ( Risedronate ) for treatment to increase bone mass in men with osteoporosis.

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.

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.
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.

In Europe, Actonel 5 mg daily and 35 mg once-a-week are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures and the treatment of established postmenopausal osteoporosis to reduce the risk of hip fractures.
Actonel 5mg daily is indicated for the prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis and to maintain or increase bone mass in post menopausal women undergoing long-term ( more than 3 months ) systemic corticosteroid treatment at doses = 7.5mg/day Prednisone or equivalent.
Actonel 35mg is indicated for the treatment of osteoporosis in men at high risk of fractures.
The 5 mg dose is not approved for males receiving systemic corticosteroid treatment and is not approved for male osteoporosis. The 35 mg dose is not approved in men or women receiving long-term systemic corticosteroids and is not approved for the prevention of osteoporosis in postmenopausal women.

In the USA, Actonel 5 mg daily and 35 mg once-a-week are indicated for the prevention and treatment of postmenopausal osteoporosis in women.
Actonel 35 mg once-a-week is indicated to increase bone mass in men with osteoporosis.
Actonel 5mg daily is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment ( =7.5 mg/d Prednisone or equivalent ) for chronic diseases.

Source: Procter & Gamble, 2006


XagenaMedicine2006