Alendronate for the treatment of osteoporosis in men

N Engl J Med. 2000 Aug 31;343(9):604-10. doi: 10.1056/NEJM200008313430902.


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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Alendronate / pharmacology
  • Alendronate / therapeutic use*
  • Alkaline Phosphatase / blood
  • Analysis of Variance
  • Biomarkers / blood
  • Biomarkers / urine
  • Body Height / drug effects
  • Bone Density / drug effects*
  • Calcium / blood
  • Collagen / urine
  • Collagen Type I
  • Double-Blind Method
  • Estradiol / blood
  • Humans
  • Male
  • Middle Aged
  • Osteoporosis / drug therapy*
  • Osteoporosis / physiopathology
  • Peptides / urine
  • Phosphates / blood
  • Spinal Fractures / epidemiology
  • Spinal Fractures / prevention & control
  • Testosterone / blood


  • Biomarkers
  • Collagen Type I
  • Peptides
  • Phosphates
  • collagen type I trimeric cross-linked peptide
  • Testosterone
  • Estradiol
  • Collagen
  • Alkaline Phosphatase
  • Calcium
  • Alendronate