OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hip osteoarthritis

被引：23
|
作者：
Lane, N. E. [1 ]
Hochberg, M. C. [2 ]
Nevitt, M. C. [3 ]
Simon, L. S. [4 ]
Nelson, A. E. [5 ]
Doherty, M. [6 ]
Herontin, Y. [7 ]
Flechsenhar, K. [8 ]
机构：
[1] Univ Calif Davis, Sch Med, Sacramento, CA 95817 USA
[2] Univ Maryland, Sch Med, Baltimore, MD 21201 USA
[3] Univ Calif San Francisco, San Francisco, CA 94143 USA
[4] SDG LLC, Cambridge, MA 02138 USA
[5] Univ N Carolina, Chapel Hill, NC 27599 USA
[6] Univ Nottingham, Sch Med, Nottingham NG7 2RD, England
[7] Dept Phys Therapy & Rehabil, Bone & Cartilage Res Unit, Marche En Famenne, Belgium
[8] Sanofi, Res & Dev, Bio Innovat, Frankfurt, Germany
来源：
OSTEOARTHRITIS AND CARTILAGE | 2015年 / 23卷 / 05期
基金：
美国国家卫生研究院;
关键词：
Clinical trial; Osteoarthritis; Hip; JOINT SPACE WIDTH; QUALITY-OF-LIFE; MCMASTER UNIVERSITIES OSTEOARTHRITIS; STRUCTURAL PROGRESSION; RADIOGRAPHIC FEATURES; KNEE OSTEOARTHRITIS; BIOCHEMICAL MARKERS; RESEARCH-SOCIETY; WESTERN ONTARIO; II COLLAGEN;
D O I：
10.1016/j.joca.2015.03.006
中图分类号：
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];
学科分类号：
摘要：
The ability to assess the efficacy and effectiveness of an intervention for the treatment of hip osteoarthritis (OA) requires strong clinical trial methodology. This consensus paper provides recommendations based on a narrative literature review and best judgment of the members of the committee for clinical trials of hip OA. We provide recommendations on clinical trial design, outcome measures, including structural (radiography), and patient and physician global assessments, performance based measures, molecular markers and experimental endpoints including MRI imaging. This information can be utilized by sponsors of trials for new therapeutic agents for hip OA. (C) 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码：761 / 771
页数：11
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