Alendronate protects premenopausal women from bone loss and fracture associated with high-dose glucocorticoid therapy.

Abstract

We assessed the efficacy of bisphosphonate in premenopausal women (n = 47) commencing high-dose glucocorticoid (GC) therapy in protection against induced bone loss and bone fracture. METHODS. Subjects had just developed systemic autoimmune diseases and were randomized to be treated with 1 mg/kg/day prednisolone and alfacalcidol 1 microg/day alone (alfacalcidol group; n = 22), or prednisolone and alfacalcidol 1 microg/day with alendronate 5 mg/day (alendronate group; n = 25), each for 18 months. The percentage changes in lumbar spine bone mineral density (BMD) after 6 months of the therapy were -10.5% +/- 0.8% in the alfacalcidol group, but only -2.1% +/- 1.2% in the combined group. The rate of bone loss in the lumbar spine was significantly lower in the combined group than in the alfacalcidol group at 6 months. At 12 months of treatment, the percentage change in lumbar spine BMD was increased by 1.7% +/- 1.4% in the combined group, but decreased by 9.9% +/- 1.9% in the alfacalcidol group; the difference was significant. Bone fracture occurred at 12 months or later in 4 patients of the alfacalcidol groups, but not in the combined group, even at up to 18 months. Our results indicate that alendronate with alfacalcidol can maintain BMD and protects against high-dose GC-induced bone loss and bone fracture.