Alendronate for osteoporosis in men
Trial question
What is the role of alendronate in male patients with osteoporosis?
Study design
Multi-center
Double blinded
RCT
Population
241 male patients
Inclusion criteria: male patients with osteoporosis
Key exclusion criteria: medical conditions associated with bone loss or other bone diseases, vitamin D deficiency, renal disease, severe cardiac disease, or history of treatment for osteoporosis
Interventions
N=146 alendronate (10 mg daily for up to2 years)
N=95 placebo (matching placebo daily for up to 2 years)
Primary outcome
Gain in bone mineral density at lumbar spine at 2 years
7.1
1.8
7.1 %
5.3 %
3.5 %
1.8 %
0.0 %
Alendronate
Placebo
Significant increase ▲
NNH = 18
Significant increase in gain in bone mineral density at the lumbar spine at 2 years (7.1% vs. 1.8%; ARD 5.3, 95% CI 4.3 to 6.3)
Secondary outcomes
Significant decrease in vertebral fractures (0.8% vs. 7.1%; RR 0.11, 95% CI 0.02 to 0.2)
Significant increase in bone mineral density at the total body at 2 years (2% vs. 0.4%; AD 1.6%, 95% CI 1 to 2.1)
Conclusion
In male patients with osteoporosis, alendronate was superior to placebo with respect to gain in bone mineral density at the lumbar spine at 2 years.
Reference
Orwoll E, Ettinger M, Weiss S et al. Alendronate for the treatment of osteoporosis in men. N Engl J Med. 2000 Aug 31;343(9):604-10.
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