Alendronate Treatment of Established Primary Osteoporosis in Men: Results of a 2-Year Prospective Study
J. D. Ringe,
H. Faber and
A. Dorst
Medizinische Klinik 4, Klinikum Leverkusen, Akademisches
Lehrkrankenhaus der Universität zu Köln, 51375 Leverkusen
Germany
Address all correspondence and requests for reprints to: Prof. Dr. Johann D. Ringe, Medizinische Klinik 4, Klinikum Leverkusen, Akademisches Lehrkrankenhaus der Universität zu Köln, 51375 Leverkusen Germany.
Abstract
Men with osteoporosis have been neglected in the past, and onlya
few therapeutic trials have been performed in men. The bisphosphonate,
alendronate,has been widely used for the treatment of postmenopausal
osteoporosis.This prospective, open label, active controlled,
randomizedclinical study compared the effects of oral alendronate (10
mgdaily) and alfacalcidol (1 µg daily) on bone mineral density
(BMD),safety, and tolerability in 134 males with primary established
osteoporosis.All men received supplemental calcium (500 mg daily).
After2 yr, alfacalcidol-treated patients showed a mean 2.8% increase
inlumbar spine BMD (P < 0.01) compared with a
mean increaseof 10.1% in men receiving alendronate
(P < 0.001). The correspondingchanges in femoral
neck BMD were +2.2% and +5.2% for the alfacalcidoland alendronate
groups, respectively (P = 0.009). The incidence
ratesof patients with new vertebral fractures were 18.2% and 7.4%
forthe alfacalcidol and alendronate groups, respectively
(P = 0.071).Both therapies were well
tolerated.
Thus, alendronate produced favorable effects on BMD consistentwith the
results from another study in male osteoporosis. Theaverage increase
rates were higher than with alfacalcidol. Alendronatemay be superior
to alfacalcidol in the treatment of men withestablished primary
osteoporosis.
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