No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.
BACKGROUND
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
ter Meulen
Cornelis G
CG
Division of Nephrology, University Medical Centre Nijmegen, The Netherlands. R.t.meulen@cwz.nl
van Riemsdijk
Iza
I
Hené
Ronald J
RJ
Christiaans
Maarten H L
MH
Borm
George F
GF
Corstens
Frans H M
FH
van Gelder
Teun
T
Hilbrands
Luuk B
LB
Weimar
Willem
W
Hoitsma
Andries J
AJ
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D015519:Bone Density / Q000187:drug effects*; D002118:Calcium / Q000097:blood; D003404:Creatinine / Q000378:metabolism; D000077561:Daclizumab; D005260:Female; D005265:Femoral Neck Fractures / Q000209:etiology / Q000517:prevention & control; D005938:Glucocorticoids / Q000008:administration & dosage*; D006084:Graft Rejection / Q000188:drug therapy*; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007668:Kidney / Q000502:physiology; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011241:Prednisone / Q000008:administration & dosage*; D011446:Prospective Studies
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D010758:Phosphorus; D003404:Creatinine; D000077561:Daclizumab; D002118:Calcium; D011241:Prednisone