Prophylactic use of alfacalcidol in corticosteroid-induced osteoporosis

One hundred and forty-five patients suffering from diseases requiring long- term treatment with high doses of corticosteroids (30 mg/day or greater of prednisolone) were recruited to the study. Patients had to be steroid naive on entry to the study (not more than 15 days of treatment with a corticost eroid within the previous 24 months). Patients were randomized to receive e ither 1 mu g/day alfacalcidol or placebo capsules for 12 months. Bone miner al density (BMD) of the lumbar spine was assessed by dual-photon absorptiom etry on entry and after 3, 6 and 12 months' treatment. Safety was monitored by the recording of all adverse events reported by patients and the regula r screening of blood samples for hematology and serum biochemistry. Of the 145 patients, 74 were randomized to alfacalcidol and 71 to placebo. The tre atment groups were well matched at baseline with no significant differences in demographic, clinical or biochemical parameters. The mean equivalent do se of prednisolone at baseline was 46.6 mg/day and 46.3 mg/day for the alfa calcidol and placebo group respectively. From the 145 patients randomized t o treatment, 71 (38 who received alfacalcidol and 33 who received placebo) provided BMD data both at baseline and at 3, 6 and 12 months. The percentag e change in BMD after 6 months' treatment was -2.11% in the alfacalcidol gr oup and -4.00% in the placebo group (p=0.39). After 12 months the percentag e change in BMD was +0.39% (CI: -4.28 to 4.81) in the alfacalcidol group an d -5.67% (CI: -8.13 to -3.21) in the placebo group, this difference (6.06%, CI: 0.88 to 11.24) being statistically significant (p=0.02). An intention to treat analysis also showed a significant difference between the two trea tment groups in alfacalcidol's favor (3.81%, p=0.01; CI: 0.92 to 6.70). The re was no significant difference between the two treatment groups in the co rticosteroid dose at any time point during the study. Serum calcium was mea sured throughout and there were no significant differences between the two treatment groups at any visit. This study suggests that alfacalcidol can pr event corticosteroid-induced bone loss from the lumbar spine. Long-term use of alfacalcidol was not associated with any significant adverse effects in this diverse group of patients.