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Previous Volume 343:604-610 August 31, 2000 Number 9 Next

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ABSTRACT

Background Despite its association with disability, death, and increased medical costs, osteoporosis in men has been relatively neglected as a subject of study. There have been no large, controlled trials of treatment in men.

Methods In a two-year double-blind trial, we studied the effect of 10 mg of alendronate or placebo, given daily, on bone mineral density in 241 men (age, 31 to 87 years; mean, 63) with osteoporosis. Approximately one third had low serum free testosterone concentrations at base line; the rest had normal concentrations. Men with other secondary causes of osteoporosis were excluded. All the men received calcium and vitamin D supplements. The main outcome measures were the percent changes in lumbar-spine, hip, and total-body bone mineral density.

Results The men who received alendronate had a mean (±SE) increase in bone mineral density of 7.1±0.3 percent at the lumbar spine, 2.5±0.4 percent at the femoral neck, and 2.0±0.2 percent for the total body (P<0.001 for all comparisons with base line). In contrast, men who received placebo had an increase in lumbar-spine bone mineral density of 1.8±0.5 percent (P<0.001 for the comparison with base line) and no significant changes in femoral-neck or total-body bone mineral density. The increase in bone mineral density in the alendronate group was greater than that in the placebo group at all measurement sites (P<0.001). The incidence of vertebral fractures was lower in the alendronate group than in the placebo group (0.8 percent vs. 7.1 percent, P=0.02). Men in the placebo group had a 2.4-mm decrease in height, as compared with a decrease of 0.6 mm in the alendronate group (P=0.02). Alendronate was generally well tolerated.

Conclusions In men with osteoporosis, alendronate significantly increases spine, hip, and total-body bone mineral density and helps prevent vertebral fractures and decreases in height.

Source Information

From Oregon Health Sciences University, Portland (E.O.); the Clinical Research Center of South Florida, Stuart (M.E.); San Diego Endocrine and Medical Clinic, San Diego, Calif. (S.W.); the Colorado Center for Bone Research, Lakewood (P.M.); Vancouver Hospital and Health Science Centre, Vancouver, B.C., Canada (D.K.); Ashford Specialist Centre, Ashford, Australia (J.G.); the University of Verona, Verona, Italy (S.A.); the University of Graz, Graz, Austria (K.W.); Children's Memorial Institute, Warsaw, Poland (R.L.); the University of Vienna, Vienna, Austria (P.P.); Merck, Brussels, Belgium (K.V.); and Merck, Rahway, N.J. (A.L.).

Address reprint requests to Dr. Orwoll at Oregon Health Sciences University (CR113), 3181 S.W. Sam Jackson Park Rd., Portland OR 97201.

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