A Phase III trial has evaluated the safety and efficacy of Risedronate ( Actonel ) for male osteoporosis.

In the trial, patients treated with Risedronate experienced a statistically significant 4.5 percent ( p<0.0001 ) increase in lumbar spine bone mineral density compared to patients receiving placebo after two years.

The double-blind, randomized, placebo-controlled, parallel group, multicenter study included 284 men ( 95 percent Caucasian ) between the ages of 36 and 84 years, inclusive, who had osteoporosis ( lumbar spine T-score less than or equal to -2.5 and femoral neck T-score less than or equal to -1 SD, or lumbar spine T-score less than or equal to -1 and femoral neck T-score less than or equal to -2 SD ) and not more than one osteoporosis-related fracture.

Study participants were randomized ( 2:1 ) to either Risedronate tablets 35 mg once a week ( n=191 ) or placebo ( n=93 ) and received daily supplements of Calcium ( 1000 mg ) and vitamin D ( 400-500 IU ) for two years.

The primary endpoint was mean percent change from baseline in lumbar spine bone mineral density relative to placebo.
Secondary endpoints included bone mineral density changes at the femoral neck, femoral trochanter, and total proximal femur, as well as percent changes from baseline in bone turnover markers including type I collagen C-telopeptide ( CTx ), type I collagen N-telopeptide/creatinine ( NTx/cr ), and bone-specific alkaline phosphatase (BAP).

Overall, Risedronate was well-tolerated, and adverse events were generally similar between patients receiving Risedronate and patients receiving placebo.
The most commonly reported adverse events were constipation, back pain, arthralgia, influenza, and nasopharyngitis.

Source: International Osteoporosis Foundation ( IOF ) World Congress on Osteoporosis, 2006


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