Objective: 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.
Results: 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.
Conclusion: Our results indicate that alendronate with alfacalcidol can maintain BMD and protects against high-dose GC-induced bone loss and bone fracture.