Overall, the data from the two alendronate studies clearly document the efficacy and safety of alendronate in osteoporotic men. The positive effects of alendronate on BMD, markers and fractures are very consistent between studies. Importantly, they are also very consistent with the results of multiple clinical studies conducted in postmenopausal women with osteoporosis. Treatment with 10 mg alendronate for 2 years produced significant and clinically meaningful increases in BMD, similar to those previously observed in postmenopausal women. Data from studies including men and women confirm the similarity of response suggested by singlegender studies. Consistent with much larger studies in postmenopausal women, alendronate 10 mg/day also reduced the incidence of new vertebral fracture and, correspondingly, reduced height loss. The safety and tolerability of alendronate in men was favorable and consistent with the safety profile previously observed in postmenopausal women. Alendronate represents an important and needed therapeutic advancement in the management of osteoporosis in men.
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism