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Risedronate Reduces Vertebral Fractures in Men With Osteoporosis: Presented at ASBMR

By Mary Beth Nierengarten

MINNEAPOLIS, MN -- September 26, 2003 -- Risedronate reduces vertebral fractures in men with primary and secondary osteoporosis after 1 year of treatment, according to a study presented here September 20^th at the 25^th Annual Meeting of the American Society for Bone and Mineral Research.

Although the efficacy of risedronate to reduce the risk of vertebral and non-vertebral fractures in postmenopausal women is well known, it has not been as studied extensively in men.

The incidence of hip fractures in men as well as women is on the increase, and projected to exceed 1.1 million by 2025. To determine the efficacy of risedronate in men with osteoporosis, Dr. J. D. Ringe, Hospital Leverkusen, Germany, conducted an open label, prospective clinical trial of 280 men with low lumber spine (LS) bone mineral density (BMD) (less than –2.5) and low total hip BMD (less than –2.0).

The men were divided into two treatment groups: Group A consisted of 69 with prevalent vertebral fractures and 71 without who were treated with 5 mg/day of risedronate plus 1000 mg calcium and 800 IU of vitamin D daily; Group B consisted of 69 men with prevalent vertebral fractures treated with 1 mcg of alfacalcidol plus 500 mg/day of calcium and 71 men without fractures treated by 1000 mg/day calcium plus 800 IU/day of vitamin D.

Incidence of secondary osteoporosis was 39% of Group A and 40% of Group B.

At Year 1, the men treated with risedronate had significantly increased BMD compared to men who did not receive the drug in the lumbar spine (4.5% versus 0.8%; P<0.0001), femoral neck (+1.7% versus +0.2%; P<0.0001), and total hip (+2.5% versus +0.3%; P<0.0001).

The men treated with risedronate also had significantly more pronounced reduction in back pain than those who did not (P<0.0001), and significantly less mean loss of height (P<0.0001).

Longer-term data will examine whether these beneficial changes seen with risedronate at 1 year are maintained at 2 and 3 years.


[Study title: Risedronate Reduces Vertebral Fractures in Men with Osteoporosis. Abstract SA355]

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