A single zoledronic acid infusion reduces bone resorption markers more rapidly than weekly oral alendronate in postmenopausal women with low bone mineral density

被引:122
作者
Saag, Kenneth
Lindsay, Robert
Kriegman, Audrey
Beamer, Emily
Zhou, Wenchun
机构
[1] Univ Alabama, Sch Med, Birmingham, AL 35294 USA
[2] Helen Hayes Hosp, W Haverstraw, NY 10993 USA
[3] Novartis Pharmaceut Corp, E Hanover, NJ 07936 USA
关键词
osteoporosis; Osteopenia; zoledronic acid; bisphosphonate; i.v; infusion; bone markers;
D O I
10.1016/j.bone.2007.01.016
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Early data suggest that an annual i.v. infusion of zoledronic acid (ZOL) might have therapeutic use in women with osteoporosis. In this randomized, double-blind, double-dummy, multicenter, 24-week trial, we evaluated the onset of action of a single infusion of ZOL 5 mg (n = 69) compared with weekly oral alendronate (ALN) 70 mg (n = 5 9) in postmenopausal women with low bone mineral density (T score <= - 2 by DXA) as assessed by reductions in urine N-telopeptide of type I collagen (NTX) at week 1. The effects of these therapies on other markers of bone turnover, patient preference for once yearly i.v. vs. oral weekly treatment, and adverse events were also assessed. At week 1, ZOL 5 mg resulted in a significantly greater reduction in mean urine NTX from baseline than ALN 70 mg (P<0.0001). Significantly greater reduction in urine NTX and serum beta-C-telopeptide of type I collagen (beta-CTX) were also observed in the ZOL 5 mg group at all post-baseline time points. Bone-specific alkaline phosphatase (BSAP) levels showed a more gradual reduction in both the ZOL 5 mg and ALN 70 mg groups, reaching premenopausal range by week 12. A comparable proportion of patients reported adverse events in each treatment group (ZOL 5 mg, 91.3%; ALN 70 mg, 86.4%). Transient, flu-like symptoms were the most common adverse events in the ZOL 5 mg group and resulted in a higher frequency of adverse events in this group during the first 3 days of treatment. After 3 days, adverse event rates were similar in the 2 groups. The majority of patients, including those experiencing flu-like symptoms, expressed a preference for annual i.v. therapy (66.4%) compared with weekly oral therapy (19.7%). We conclude that a single i.v. infusion of ZOL 5 mg reduced urine NTX levels more rapidly than weekly oral ALN 70 mg. The majority of study patients preferred an i.v. treatment regimen of ZOL 5 mg over weekly osteoporosis therapy with ALN 70 mg. (c) 2007 Elsevier Inc. All rights reserved.
引用
收藏
页码:1238 / 1243
页数:6
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