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      Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis : A Randomized, Placebo-Controlled Study

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          MIV-711 is a novel selective cathepsin K inhibitor with beneficial effects on bone and cartilage in preclinical osteoarthritis models.

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          Most cited references24

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          Increasing the reliability and validity of pain intensity measurement in chronic pain patients.

          Braden McFarland, Dorte M. Jensen (1993)
          This study examined the effects of increasing the number of assessments on the reliability and validity of measures of average pain intensity. Two hundred chronic pain patients completed 2 weeks of hourly pain ratings. A series of regression analyses were performed, and test-retest stability, internal consistency and validity coefficients were computed to address 4 questions. (1) Are chronic pain patients' reports of pain similar from one day to another? (2) What is the reliability and validity of a single rating of pain intensity when used as an indicant of average pain? (3) How many assessments (data points) are required to obtain estimates of average pain intensity with adequate to excellent psychometric properties? (4) How important is it to sample pain from different days? The results were consistent with predictions based on patients' self-reports of their pain and on psychometric theory. First, the majority of patients did not report similar levels of pain from one day to another, and average pain scores calculated from ratings obtained from a single day were less stable than those calculated from ratings obtained from multiple days. Also, and as expected, the results indicate that a single rating of pain intensity is not adequately reliable or valid as a measure of average pain. However, a composite pain intensity score calculated from an average of 12 ratings across 4 days demonstrated adequate reliability and excellent validity as a measure of the average pain in this sample of chronic pain patients.(ABSTRACT TRUNCATED AT 250 WORDS)
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            Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis.

            V.B. Kraus, B Burnett, J Coindreau … (2011)
            Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the Osteoarthritis Research Society International Federal Drug Administration initiative (OARSI FDA initiative). This document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers. Although many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within 1-2 years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent. Copyright © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
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              Predictive validity of biochemical biomarkers in knee osteoarthritis: data from the FNIH OA Biomarkers Consortium.

              Virginia Byers Kraus, Jamie Collins, David Hargrove … (2017)
              To investigate a targeted set of biochemical biomarkers as predictors of clinically relevant osteoarthritis (OA) progression.
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                Author and article information

                Journal
                Title: Annals of Internal Medicine
                Abbreviated Title: Ann Intern Med
                Publisher: American College of Physicians
                ISSN (Print): 0003-4819
                Publication date (Electronic): December 31 2019
                Affiliations
                [1 ]Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom (P.G.C., S.R.K.)
                [2 ]Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.)
                [3 ]Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.)
                Article
                DOI: 10.7326/M19-0675
                PubMed ID: 31887743
                SO-VID: 132b4e94-3cd1-4115-8984-d73a0603151c
                Copyright © © 2019
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