The effect of teriparatide compared with risedronate on reduction of back pain in postmenopausal women with osteoporotic vertebral fractures

被引:121
作者
Hadji, P. [1 ,2 ]
Zanchetta, J. R. [3 ]
Russo, L. [4 ]
Recknor, C. P. [5 ]
Saag, K. G. [6 ]
McKiernan, F. E. [7 ]
Silverman, S. L. [8 ,9 ]
Alam, J. [10 ]
Burge, R. T. [10 ]
Krege, J. H. [10 ]
Lakshmanan, M. C. [10 ]
Masica, D. N. [10 ]
Mitlak, B. H. [10 ]
Stock, J. L. [10 ]
机构
[1] Univ Klinikum Giessen & Marburg GmbH, Klin Gynakol Gynakol Endokrinol & Onkol, Leiter Schwerpunkts Gynekol Endokrinol Reproduk M, D-35033 Marburg, Germany
[2] Univ Marburg, Dept Endocrinol Osteoporosis & Reprod Med, Marburg, Germany
[3] IDIM, Buenos Aires, DF, Argentina
[4] CCBR Brazil Clin Res Ctr, Rio De Janeiro, Brazil
[5] United Osteoporosis Ctr, Gainesville, GA USA
[6] Univ Alabama Birmingham, Birmingham, AL USA
[7] Marshfield Clin Fdn Med Res & Educ, Ctr Bone Dis, Marshfield, WI USA
[8] Cedars Sinai UCLA, Beverly Hills, CA USA
[9] OMC Clin Res Ctr, Beverly Hills, CA USA
[10] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN 46285 USA
关键词
Back pain; Bisphosphonate; Osteoporosis; Teriparatide; Vertebral fracture; QUALITY-OF-LIFE; GLUCOCORTICOID-INDUCED OSTEOPOROSIS; CLINICAL IMPORTANCE; BONE-DENSITY; RISK; ALENDRONATE; OUTCOMES; CONSEQUENCES; METAANALYSIS; DEFORMITIES;
D O I
10.1007/s00198-011-1856-y
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The effect of teriparatide and risedronate on back pain was tested, and there was no difference in the proportion of patients experiencing a reduction in back pain between groups after 6 or 18 months. Patients receiving teriparatide had greater increases in bone mineral density and had fewer vertebral fractures. This study aimed to understand the effect of teriparatide in reducing back pain in patients with prevalent back pain and vertebral fracture compared to risedronate. In an 18-month randomized, double-blind, double-dummy trial, we investigated the effects of teriparatide (20 mu g/day) vs. risedronate (35 mg/week) in postmenopausal women with back pain likely due to vertebral fracture. The primary objective was to compare the proportion of subjects reporting a parts per thousand yen30% reduction in worst back pain severity from baseline to 6 months as assessed by a numeric rating scale in each treatment group. Pre-specified secondary and exploratory outcomes included assessments of average and worst back pain at additional time points, disability and quality of life, bone mineral density, incidence of fractures, and safety. At 6 months, 59% of teriparatide and 57% of risedronate patients reported a parts per thousand yen30% reduction in worst back pain and there were no differences between groups in the proportion of patients experiencing reduction in worst or average back pain at any time point, disability, or quality of life. There was a greater increase from baseline in bone mineral density at the lumbar spine (p = 0.001) and femoral neck (p = 0.02) with teriparatide compared to risedronate and a lower incidence of vertebral fractures at 18 months (4% teriparatide and 9% risedronate; p = 0.01). Vertebral fractures were less severe (p = 0.04) in the teriparatide group. There was no difference in the overall incidence of adverse events. Although there were no differences in back pain-related endpoints, patients receiving teriparatide had greater skeletal benefit than those receiving risedronate.
引用
收藏
页码:2141 / 2150
页数:10
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