Dose Study of Thymoglobulin During Conditioning for Unrelated Donor Allogeneic Stem-Cell Transplantation

Abstract

Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal transplantation. A total of 364 recipients of a renal transplant were randomized to receive either daclizumab (1 mg/kg on days 0 and 10 after transplantation; steroid-free group n=186) or prednisone (0.3 mg/kg per day tapered to 0 mg at week 16 after transplantation; steroids group n=178). All patients received tacrolimus, mycophenolate mofetil, and, during the first 3 days, 100 mg prednisolone intravenously. Changes in bone mineral density (BMD) were evaluated in 135 and 126 patients in the steroid-free and steroids group, respectively. The mean (+/- SD) BMD of the lumbar spine decreased slightly in both groups during the first 3 months after transplantation (steroid-free -1.3 +/- 4.0% [P<0.01]; steroids -2.3 +/-4.2% [P<0.01]). In the following months, lumbar BMD recovered in both groups (P<0.01), resulting in a lumbar BMD at 12 months after transplantation comparable with the baseline value. No difference between the groups was found at 3 months (steroid-free versus steroids +1.0%; 95% confidence interval -0.0%-+2.0%, P=0.060) and at 12 months after transplantation (steroid-free versus steroids +0.9%; 95% confidence interval -0.8%-+2.6%, NS). The use of a moderate dose of steroids during 4 months after transplantation has no important influence on bone mass during the first year after renal transplantation. On average, both regimens prevented accelerated bone loss.