A Single Dose of Intravenous Zoledronate Prevents Glucocorticoid Therapy-Associated Bone Loss in Acute Flare of Crohn's Disease, a Randomized Controlled Trial

作者：Klaus Jochen^*; Haenle M M; Schroeter C; Adler G; von Boyen G; Reinshagen M; von Tirpitz C

来源：American Journal of Gastroenterology, 2011, 106(4): 786-793.

DOI：10.1038/ajg.2011.59

OBJECTIVES: To assess the effectiveness and safety of zoledronate (ZOL) in preventing glucocorticoid therapy-associated bone loss in patients with acute flare of Crohn's disease (CD) in a randomized, double-blind, placebo-controlled trial.
METHODS: Forty CD patients starting a glucocorticoid therapy (60 mg prednisolone per day) for acute flare (CD activity index (CDAI) > 220) were randomized to compare the effect of ZOL (4 mg intravenous, n = 20) or placebo (n = 20) on change in lumbar bone mineral density (BMD). All patients received calcium citrate (800 mg) and colecalciferol (1,000 IU) daily. Dual energy X-ray absorptiometry (DXA) of the lumbar spine (L1-L4) was performed at baseline and day 90. Follow-up examinations at day 1/7/14/30 and 90 included laboratory tests and adverse event/serious adverse events reports.
RESULTS: Thirty-six patients were available for per-protocol analysis. With placebo (n = 18), a decrease in BMD was seen (T-score: -0.98 +/- 0.8, day 0 and -1.25 +/- 0.77, day 90, P = 0.06), with ZOL (n = 18) BMD increased (-1.15 +/- 1.02, day 0 and -0.74 +/- 1.09, day 90, P = 0.03). The change in BMD under placebo (-0.26 +/- 0.21) vs. ZOL (+ 0.41 +/- 0.19) was highly significant (P = 0.006). In all, 14 out of 18 patients with ZOL had an increase in BMD (+ 0.64 +/- 0.48), 12 of 18 with placebo a decrease (-0.50 +/- 0.39). Changes of clinical findings and laboratory results of inflammation (leukocytes, platelets, and C-reactive protein) were the same in-and between-groups throughout the study. With ZOL, serum bone degradation marker beta-Cross-Laps decreased. Study medication was safe and well tolerated.
CONCLUSIONS: ZOL is effective in preventing glucocorticoid therapy-induced bone loss in patients with acute flare of CD and should be considered whenever a glucocorticoid therapy is started in CD patients.

• 出版日期2011-4