Alendronate for the treatment of osteoporosis in men.
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.
Orwoll
E
E
Oregon Health Sciences University, Portland 97201, USA.
Ettinger
M
M
Weiss
S
S
Miller
P
P
Kendler
D
D
Graham
J
J
Adami
S
S
Weber
K
K
Lorenc
R
R
Pietschmann
P
P
Vandormael
K
K
Lombardi
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000494:pharmacology / Q000627:therapeutic use*; D000469:Alkaline Phosphatase / Q000097:blood; D000704:Analysis of Variance; D015415:Biomarkers / Q000097:blood / Q000652:urine; D001827:Body Height / Q000187:drug effects; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000097:blood; D003094:Collagen / Q000652:urine; D024042:Collagen Type I; D004311:Double-Blind Method; D004958:Estradiol / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000503:physiopathology; D010455:Peptides / Q000652:urine; D010710:Phosphates / Q000097:blood; D016103:Spinal Fractures / Q000453:epidemiology / Q000517:prevention & control; D013739:Testosterone / Q000097:blood
D015415:Biomarkers; D024042:Collagen Type I; D010455:Peptides; D010710:Phosphates; C052929:collagen type I trimeric cross-linked peptide; D013739:Testosterone; D004958:Estradiol; D003094:Collagen; D000469:Alkaline Phosphatase; D002118:Calcium; D019386:Alendronate