Alendronate Phase III Osteoporosis Treatment Study
Trial question
What is the role of alendronate therapy in postmenopausal patients with osteoporosis?
Study design
Multi-center
Double blinded
RCT
Population
994 female patients
Inclusion criteria: postmenopausal female patients with osteoporosis
Key exclusion criteria: treatment with corticosteroids, vitamin D deficiency, Paget's disease, or hyperparathyroidism, active peptic ulcer disease, abnormal renal function, or abnormal hepatic function
Interventions
N=526 alendronate (5 or 10 mg daily for three years, or 20 mg for two years followed by 5 mg for one year)
N=355 placebo (matching placebo)
Primary outcome
New vertebral fractures
3.2
6.2
6.2 %
4.7 %
3.1 %
1.6 %
0.0 %
Alendronate
Placebo
Significant decrease ▼
NNT = 33
Significant decrease in new vertebral fractures (3.2% vs. 6.2%; RR 0.52, 95% CI 0.28 to 0.95)
Secondary outcomes
Significant decrease in progression of vertebral deformities (33% vs. 41%; RR 0.8, 95% CI 0.09 to 1.51)
Safety outcomes
No significant difference in adverse events.
Conclusion
In postmenopausal female patients with osteoporosis, alendronate was superior to placebo with respect to new vertebral fractures.
Reference
Liberman UA, Weiss SR, Broll J et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med. 1995 Nov 30;333(22):1437-43.
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