title: OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hip osteoarthritis.
abstract: 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.
authors.affiliation: University of California at Davis School of Medicine, Sacramento, CA 95817, USA. Electronic address: nelane@ucdavis.edu.
authors.forename: N E
authors.initials: NE
authors.lastname: Lane
authors.affiliation: University of Maryland, School of Medicine, Baltimore, MD 21201, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Hochberg
authors.affiliation: University of California at San Francisco, San Francisco, CA 94143, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Nevitt
authors.affiliation: SDG LLC, Cambridge, MA 02138, USA.
authors.forename: L S
authors.initials: LS
authors.lastname: Simon
authors.affiliation: University of North Carolina, Chapel Hill, NC 27599, USA.
authors.forename: A E
authors.initials: AE
authors.lastname: Nelson
authors.affiliation: University of Nottingham, School of Medicine, Nottingham, UK.
authors.forename: M
authors.initials: M
authors.lastname: Doherty
authors.forename: Y
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: Bone and Cartilage Research Unit, Department of Physical Therapy and Rehabilitation, Marche-en-Famenne, Belgium.
authors.forename: Y
authors.initials: Y
authors.lastname: Herontin
authors.affiliation: Sanofi, Research and Development, Bio Innovation, Frankfurt, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Flechsenhar
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D019468:Disease Management; D006801:Humans; D015207:Osteoarthritis, Hip / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D017410:Practice Guidelines as Topic
keywords: Clinical trial; Hip; Osteoarthritis