Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON-Recurrent Fracture Trial

被引:29
作者
Adachi, J. D. [1 ]
Lyles, K. W. [2 ,3 ]
Colon-Emeric, C. S. [2 ,3 ]
Boonen, S. [4 ]
Pieper, C. F. [2 ,3 ]
Mautalen, C. [5 ]
Hyldstrup, L. [6 ]
Recknor, C. [7 ]
Nordsletten, L. [8 ]
Moore, K. A. [2 ,3 ]
Bucci-Rechtweg, C. [9 ]
Su, G. [9 ]
Eriksen, E. F. [10 ]
Magaziner, J. S. [11 ]
机构
[1] McMaster Univ, St Josephs Healthcare, Hamilton, ON L8N 1Y2, Canada
[2] Duke Univ, Med Ctr, Durham, NC USA
[3] Vet Affairs Med Ctr, Geriatr Res Educ & Clin Ctr, Durham, NC USA
[4] Univ Louvain, Louvain, Belgium
[5] Ctr Osteopatias Med, Buenos Aires, DF, Argentina
[6] Univ Copenhagen, Hvidovre Hosp, DK-2650 Hvidovre, Denmark
[7] United Osteoporosis Ctr, Gainesville, GA USA
[8] Ullevaal Univ Hosp, Oslo, Norway
[9] Novartis Pharmaceut, E Hanover, NJ USA
[10] Oslo Univ Hosp Aker, Oslo, Norway
[11] Univ Maryland, Baltimore, MD 21201 USA
关键词
EQ-5D; Health-related QoL; Low-trauma hip fracture; Zoledronic acid; CANADIAN MULTICENTER OSTEOPOROSIS; INCIDENT VERTEBRAL FRACTURES; POSTMENOPAUSAL WOMEN; ELDERLY-WOMEN; PREVALENT; EUROQOL; IMPACT; ASSOCIATION; OUTCOMES;
D O I
10.1007/s00198-010-1514-9
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
This study evaluated the benefits of ZOL versus placebo on health-related quality of life (HRQoL) among patients from HORIZON-RFT. At month 24 and end of the study visit, ZOL significantly improved patients' overall health state compared to placebo as assessed by the EQ-5D VAS. Introduction To evaluate the benefits of zoledronic acid (ZOL) versus placebo on health-related quality of life (HRQoL) among patients from The Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly Recurrent Fracture Trial (HORIZON-RFT). Methods In this randomized, double-blind, placebo-controlled trial, 2,127 patients were randomized to receive annual infusion of ZOL 5 mg (n = 1,065) or placebo (n = 1,062) within 90 days after surgical repair of low-trauma hip fracture. HRQoL was measured using EQ-5D Visual Analogue Scale (VAS) and utility scores (EuroQol instrument) at months 6, 12, 24, 36, and end of the study visit. Analysis of covariance model included baseline EQ-5D value, region, and treatment as explanatory variables. Results At baseline, patients (mean age 75 years; 24% men and 76% women) were well matched between treatment groups with mean EQ-5D VAS of 65.82 in ZOL and 65.70 in placebo group. At the end of the study, mean change from baseline in EQ-5D VAS was greater for ZOL vs. placebo in all patients (7.67 +/- 0.56 vs. 5.42 +/- 0.56), and in subgroups of patients experiencing clinical vertebral fractures (8.86 +/- 4.91 vs. -1.69 +/- 3.42), non-vertebral fractures (5.03 +/- 2.48 vs. -1.07 +/- 2.16), and clinical fractures (5.19 +/- 2.25 vs. -0.72 +/- 1.82) with treatment difference significantly in favor of ZOL. EQ-5D utility scores were comparable for ZOL and placebo groups, but more patients on placebo consistently had extreme difficulty in mobility (1.74% for ZOL vs. 2.13% for placebo; p = 0.6238), self-care (4.92% vs. 6.69%; p = 0.1013), and usual activities (10.28% vs. 12.91%; p = 0.0775). Conclusion ZOL significantly improves HRQoL in patients with low-trauma hip fracture.
引用
收藏
页码:2539 / 2549
页数:11
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