Skip to main content
Top
Published in: Skeletal Radiology 11/2023

Open Access 24-01-2023 | Osteoarthrosis | Review Article

Biomarkers in osteoarthritis: current status and outlook — the FNIH Biomarkers Consortium PROGRESS OA study

Authors: David J. Hunter, Jamie E. Collins, Leticia Deveza, Steven C. Hoffmann, Virginia B. Kraus

Published in: Skeletal Radiology | Issue 11/2023

Login to get access

Abstract

Currently, no disease-modifying therapies are approved for osteoarthritis (OA) use. One obstacle to trial success in this field has been our existing endpoints’ limited validity and responsiveness. To overcome this impasse, the Foundation for the NIH OA Biomarkers Consortium is focused on investigating biomarkers for a prognostic context of use for subsequent qualification through regulatory agencies. This narrative review describes this activity and the work underway, focusing on the PROGRESS OA study.
Literature
1.
go back to reference Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014;10(7):437–41.CrossRefPubMed Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014;10(7):437–41.CrossRefPubMed
2.
go back to reference Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020;396(10264):1711–2.CrossRefPubMed Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020;396(10264):1711–2.CrossRefPubMed
3.
go back to reference Prevalence of disabilities and associated health conditions among adults--United States, 1999. MMWR Morb Mortal Wkly Rep. 2001;50(7):120–5 erratum appears in MMWR Morb Mortal Wkly Rep 2001;50(8):149. Prevalence of disabilities and associated health conditions among adults--United States, 1999. MMWR Morb Mortal Wkly Rep. 2001;50(7):120–5 erratum appears in MMWR Morb Mortal Wkly Rep 2001;50(8):149.
4.
go back to reference Guccione AA, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health. 1994;84(3):351–8.CrossRefPubMedPubMedCentral Guccione AA, et al. The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health. 1994;84(3):351–8.CrossRefPubMedPubMedCentral
5.
go back to reference Hunter DJ, et al. A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials. Curr Drug Targets. 2010;11(5):536–45.CrossRefPubMedPubMedCentral Hunter DJ, et al. A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials. Curr Drug Targets. 2010;11(5):536–45.CrossRefPubMedPubMedCentral
6.
go back to reference Oo WM, et al. The development of disease-modifying therapies for osteoarthritis (DMOADs): the evidence to date. Drug Des Devel Ther. 2021;15:2921–45.CrossRefPubMedPubMedCentral Oo WM, et al. The development of disease-modifying therapies for osteoarthritis (DMOADs): the evidence to date. Drug Des Devel Ther. 2021;15:2921–45.CrossRefPubMedPubMedCentral
7.
go back to reference Eckstein F, et al. Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial. Ann Rheum Dis. 2020;79(4):525–8.CrossRefPubMed Eckstein F, et al. Intra-articular sprifermin reduces cartilage loss in addition to increasing cartilage gain independent of location in the femorotibial joint: post-hoc analysis of a randomised, placebo-controlled phase II clinical trial. Ann Rheum Dis. 2020;79(4):525–8.CrossRefPubMed
8.
go back to reference Conaghan PG, et al. Disease-modifying effects of a novel cathepsin K inhibitor in osteoarthritis: a randomized controlled trial. Ann Intern Med. 2020;172(2):86–95.CrossRefPubMed Conaghan PG, et al. Disease-modifying effects of a novel cathepsin K inhibitor in osteoarthritis: a randomized controlled trial. Ann Intern Med. 2020;172(2):86–95.CrossRefPubMed
10.
go back to reference Burstein D, Hunter DJ. "Why aren’t we there yet?" Re-examining standard paradigms in imaging of OA: summary of the 2nd annual workshop on imaging based measures of osteoarthritis. Osteoarthritis Cartilage. 2009;17(5):571–8.CrossRefPubMed Burstein D, Hunter DJ. "Why aren’t we there yet?" Re-examining standard paradigms in imaging of OA: summary of the 2nd annual workshop on imaging based measures of osteoarthritis. Osteoarthritis Cartilage. 2009;17(5):571–8.CrossRefPubMed
12.
go back to reference Mazzuca SA, Brandt KD. Is knee radiography useful for studying the efficacy of a disease-modifying osteoarthritis drug in humans?. [Review] [22 refs]. Rheum Dis Clin North Am. 2003;29(4):819–30.CrossRefPubMed Mazzuca SA, Brandt KD. Is knee radiography useful for studying the efficacy of a disease-modifying osteoarthritis drug in humans?. [Review] [22 refs]. Rheum Dis Clin North Am. 2003;29(4):819–30.CrossRefPubMed
13.
go back to reference Mazzuca SA, et al. Pitfalls in the accurate measurement of joint space narrowing in semiflexed, anteroposterior radiographic imaging of the knee. Arthritis Rheum. 2004;50(8):2508–15.CrossRefPubMed Mazzuca SA, et al. Pitfalls in the accurate measurement of joint space narrowing in semiflexed, anteroposterior radiographic imaging of the knee. Arthritis Rheum. 2004;50(8):2508–15.CrossRefPubMed
14.
go back to reference Hunter DJ, et al. Biomarkers for osteoarthritis: current position and steps towards further validation. Best Prac. Res Clin Rheumatol. 2014;28(1):61–71.CrossRef Hunter DJ, et al. Biomarkers for osteoarthritis: current position and steps towards further validation. Best Prac. Res Clin Rheumatol. 2014;28(1):61–71.CrossRef
15.
go back to reference Menetski JP, et al. The Foundation for the National Institutes of Health Biomarkers Consortium: past accomplishments and new strategic direction. Clin Pharmacol Ther. 2019;105(4):829–43.CrossRefPubMedPubMedCentral Menetski JP, et al. The Foundation for the National Institutes of Health Biomarkers Consortium: past accomplishments and new strategic direction. Clin Pharmacol Ther. 2019;105(4):829–43.CrossRefPubMedPubMedCentral
17.
go back to reference Eckstein F, et al. Cartilage thickness change as an imaging biomarker of knee osteoarthritis progression - data from the foundation for the National Institutes of Health Osteoarthritis biomarkers consortium. Arthritis Rheumatol. 2015;67:3184–9.CrossRefPubMedPubMedCentral Eckstein F, et al. Cartilage thickness change as an imaging biomarker of knee osteoarthritis progression - data from the foundation for the National Institutes of Health Osteoarthritis biomarkers consortium. Arthritis Rheumatol. 2015;67:3184–9.CrossRefPubMedPubMedCentral
18.
go back to reference Roemer FW, et al. Semi-quantitative MRI biomarkers of knee osteoarthritis progression in the FNIH biomarkers consortium cohort - methodologic aspects and definition of change. BMC Musculoskelet Disord. 2016;17(1):466.CrossRefPubMedPubMedCentral Roemer FW, et al. Semi-quantitative MRI biomarkers of knee osteoarthritis progression in the FNIH biomarkers consortium cohort - methodologic aspects and definition of change. BMC Musculoskelet Disord. 2016;17(1):466.CrossRefPubMedPubMedCentral
19.
go back to reference Collins JE, et al. Semiquantitative imaging biomarkers of knee osteoarthritis progression: data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2016;68(10):2422–31.CrossRefPubMedPubMedCentral Collins JE, et al. Semiquantitative imaging biomarkers of knee osteoarthritis progression: data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2016;68(10):2422–31.CrossRefPubMedPubMedCentral
20.
go back to reference Kraus VB, et al. Predictive validity of biochemical biomarkers in knee osteoarthritis: data from the FNIH OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):186–95.CrossRefPubMed Kraus VB, et al. Predictive validity of biochemical biomarkers in knee osteoarthritis: data from the FNIH OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):186–95.CrossRefPubMed
21.
go back to reference Kraus VB, et al. Predictive validity of radiographic trabecular bone texture in knee osteoarthritis: the Osteoarthritis Research Society International/Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2018;70(1):80–7.CrossRefPubMed Kraus VB, et al. Predictive validity of radiographic trabecular bone texture in knee osteoarthritis: the Osteoarthritis Research Society International/Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2018;70(1):80–7.CrossRefPubMed
22.
go back to reference Hunter DJ, et al. Multivariable modeling of biomarker data from the phase 1 Foundation for the NIH Osteoarthritis Biomarkers Consortium. Arthritis Care Res (Hoboken). 2022;74(7):1142–53.CrossRefPubMedPubMedCentral Hunter DJ, et al. Multivariable modeling of biomarker data from the phase 1 Foundation for the NIH Osteoarthritis Biomarkers Consortium. Arthritis Care Res (Hoboken). 2022;74(7):1142–53.CrossRefPubMedPubMedCentral
23.
go back to reference Bauer DC, et al. Classification of osteoarthritis biomarkers: a proposed approach. Osteoarthritis Cartilage. 2006;14(8):723–7.CrossRefPubMed Bauer DC, et al. Classification of osteoarthritis biomarkers: a proposed approach. Osteoarthritis Cartilage. 2006;14(8):723–7.CrossRefPubMed
24.
go back to reference Enrichment strategies for clinical trials to support approval of human drugs and biological products. 2016. Enrichment strategies for clinical trials to support approval of human drugs and biological products. 2016.
25.
go back to reference Almhdie-Imjabbar A, et al. Trabecular bone texture analysis of conventional radiographs in the assessment of knee osteoarthritis: review and viewpoint. Arthritis Res Ther. 2021;23(1):208.CrossRefPubMedPubMedCentral Almhdie-Imjabbar A, et al. Trabecular bone texture analysis of conventional radiographs in the assessment of knee osteoarthritis: review and viewpoint. Arthritis Res Ther. 2021;23(1):208.CrossRefPubMedPubMedCentral
26.
go back to reference Kraus VB, et al. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009;60(12):3711–22.CrossRefPubMedPubMedCentral Kraus VB, et al. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009;60(12):3711–22.CrossRefPubMedPubMedCentral
27.
go back to reference Peterfy CG, et al. Whole-organ magnetic resonance imaging score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004;12(3):177–90.CrossRefPubMed Peterfy CG, et al. Whole-organ magnetic resonance imaging score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004;12(3):177–90.CrossRefPubMed
28.
go back to reference Biswal S, et al. Risk factors for progressive cartilage loss in the knee: a longitudinal magnetic resonance imaging study in forty-three patients. Arthritis Rheum. 2002;46(11):2884–92.CrossRefPubMed Biswal S, et al. Risk factors for progressive cartilage loss in the knee: a longitudinal magnetic resonance imaging study in forty-three patients. Arthritis Rheum. 2002;46(11):2884–92.CrossRefPubMed
29.
go back to reference Hunter D, et al. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008;67(2):206–11.CrossRefPubMed Hunter D, et al. The reliability of a new scoring system for knee osteoarthritis MRI and the validity of bone marrow lesion assessment: BLOKS (Boston Leeds Osteoarthritis Knee Score). Ann Rheum Dis. 2008;67(2):206–11.CrossRefPubMed
30.
go back to reference Kornaat PR, et al. MRI assessment of knee osteoarthritis: knee osteoarthritis scoring system (KOSS)--inter-observer and intra-observer reproducibility of a compartment-based scoring system. Skeletal Radiol. 2005;34(2):95–102.CrossRefPubMed Kornaat PR, et al. MRI assessment of knee osteoarthritis: knee osteoarthritis scoring system (KOSS)--inter-observer and intra-observer reproducibility of a compartment-based scoring system. Skeletal Radiol. 2005;34(2):95–102.CrossRefPubMed
31.
go back to reference Hunter D, Hellio Le Graverand M, Eckstein F. Radiologic markers of osteoarthritis progression. Curr Opin Rheumatol. 2009;21(2):110–7.CrossRefPubMed Hunter D, Hellio Le Graverand M, Eckstein F. Radiologic markers of osteoarthritis progression. Curr Opin Rheumatol. 2009;21(2):110–7.CrossRefPubMed
32.
go back to reference Eckstein F, Burstein D, Link TM. Quantitative MRI of cartilage and bone: degenerative changes in osteoarthritis. [Review] [238 refs]. NMR Biomed. 2006;19(7):822–54.CrossRefPubMed Eckstein F, Burstein D, Link TM. Quantitative MRI of cartilage and bone: degenerative changes in osteoarthritis. [Review] [238 refs]. NMR Biomed. 2006;19(7):822–54.CrossRefPubMed
33.
go back to reference Burgkart R, et al. Magnetic resonance imaging-based assessment of cartilage loss in severe osteoarthritis: accuracy, precision, and diagnostic value. Arthritis Rheum. 2001;44(9):2072–7.CrossRefPubMed Burgkart R, et al. Magnetic resonance imaging-based assessment of cartilage loss in severe osteoarthritis: accuracy, precision, and diagnostic value. Arthritis Rheum. 2001;44(9):2072–7.CrossRefPubMed
34.
go back to reference Graichen H, et al. Quantitative assessment of cartilage status in osteoarthritis by quantitative magnetic resonance imaging: technical validation for use in analysis of cartilage volume and further morphologic parameters. Arthritis Rheum. 2004;50(3):811–6.CrossRefPubMed Graichen H, et al. Quantitative assessment of cartilage status in osteoarthritis by quantitative magnetic resonance imaging: technical validation for use in analysis of cartilage volume and further morphologic parameters. Arthritis Rheum. 2004;50(3):811–6.CrossRefPubMed
35.
go back to reference Berthiaume MJ, et al. Meniscal tear and extrusion are strongly associated with progression of symptomatic knee osteoarthritis as assessed by quantitative magnetic resonance imaging. Ann Rheum Dis. 2005;64(4):556–63.CrossRefPubMed Berthiaume MJ, et al. Meniscal tear and extrusion are strongly associated with progression of symptomatic knee osteoarthritis as assessed by quantitative magnetic resonance imaging. Ann Rheum Dis. 2005;64(4):556–63.CrossRefPubMed
36.
37.
go back to reference Cicuttini FM, et al. Rate of cartilage loss at two years predicts subsequent total knee arthroplasty: a prospective study. Ann Rheum Dis. 2004;63(9):1124–7.CrossRefPubMedPubMedCentral Cicuttini FM, et al. Rate of cartilage loss at two years predicts subsequent total knee arthroplasty: a prospective study. Ann Rheum Dis. 2004;63(9):1124–7.CrossRefPubMedPubMedCentral
38.
go back to reference Raynauld JP, et al. Quantitative magnetic resonance imaging evaluation of knee osteoarthritis progression over two years and correlation with clinical symptoms and radiologic changes. Arthritis Rheum. 2004;50(2):476–87.CrossRefPubMed Raynauld JP, et al. Quantitative magnetic resonance imaging evaluation of knee osteoarthritis progression over two years and correlation with clinical symptoms and radiologic changes. Arthritis Rheum. 2004;50(2):476–87.CrossRefPubMed
39.
go back to reference Cicuttini F, et al. Gender differences in knee cartilage volume as measured by magnetic resonance imaging. Osteoarthr Cartil 1999;7(3):265–71.CrossRefPubMed Cicuttini F, et al. Gender differences in knee cartilage volume as measured by magnetic resonance imaging. Osteoarthr Cartil 1999;7(3):265–71.CrossRefPubMed
40.
go back to reference Peterfy C, et al. Quantification of articular cartilage in the knee with pulsed saturation transfer subtraction and fat-suppressed MR imaging: optimization and validation. Radiology. 1994;192(2):485–91.CrossRefPubMed Peterfy C, et al. Quantification of articular cartilage in the knee with pulsed saturation transfer subtraction and fat-suppressed MR imaging: optimization and validation. Radiology. 1994;192(2):485–91.CrossRefPubMed
41.
go back to reference Kshirsagar AA, et al. Measurement of localized cartilage volume and thickness of human knee joints by computer analysis of three-dimensional magnetic resonance images. Invest Radiol. 1998;33(5):289–99.CrossRefPubMed Kshirsagar AA, et al. Measurement of localized cartilage volume and thickness of human knee joints by computer analysis of three-dimensional magnetic resonance images. Invest Radiol. 1998;33(5):289–99.CrossRefPubMed
42.
go back to reference Kraus VB, et al. Subchondral bone trabecular integrity predicts and changes concurrently with radiographic and magnetic resonance imaging-determined knee osteoarthritis progression. Arthritis Rheum. 2013;65(7):1812–21.CrossRefPubMedPubMedCentral Kraus VB, et al. Subchondral bone trabecular integrity predicts and changes concurrently with radiographic and magnetic resonance imaging-determined knee osteoarthritis progression. Arthritis Rheum. 2013;65(7):1812–21.CrossRefPubMedPubMedCentral
43.
go back to reference Janvier T, et al. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the osteoarthritis initiative: tibial bone texture & knee OA progression. Osteoarthritis Cartilage. 2017;25(2):259–66.CrossRefPubMed Janvier T, et al. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the osteoarthritis initiative: tibial bone texture & knee OA progression. Osteoarthritis Cartilage. 2017;25(2):259–66.CrossRefPubMed
44.
go back to reference Almhdie-Imjabbar A, et al. Prediction of knee osteoarthritis progression using radiological descriptors obtained from bone texture analysis and Siamese neural networks: data from OAI and MOST cohorts. Arthritis Res Ther. 2022;24(1):66.CrossRefPubMedPubMedCentral Almhdie-Imjabbar A, et al. Prediction of knee osteoarthritis progression using radiological descriptors obtained from bone texture analysis and Siamese neural networks: data from OAI and MOST cohorts. Arthritis Res Ther. 2022;24(1):66.CrossRefPubMedPubMedCentral
45.
go back to reference Kraus VB, et al. Establishment of reference intervals for osteoarthritis-related soluble biomarkers: the FNIH/OARSI OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):179–85.CrossRefPubMed Kraus VB, et al. Establishment of reference intervals for osteoarthritis-related soluble biomarkers: the FNIH/OARSI OA Biomarkers Consortium. Ann Rheum Dis. 2017;76(1):179–85.CrossRefPubMed
46.
go back to reference Hellio Le Graverand MP, et al. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis. 2013;72(2):187–95.CrossRefPubMed Hellio Le Graverand MP, et al. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis. 2013;72(2):187–95.CrossRefPubMed
47.
go back to reference Hellio Le Graverand MP, et al. Considerations when designing a disease-modifying osteoarthritis drug (DMOAD) trial using radiography. Semin Arthritis Rheum. 2013;43(1):1–8.CrossRefPubMed Hellio Le Graverand MP, et al. Considerations when designing a disease-modifying osteoarthritis drug (DMOAD) trial using radiography. Semin Arthritis Rheum. 2013;43(1):1–8.CrossRefPubMed
48.
go back to reference Karsdal MA, et al. Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Osteoarthritis Cartilage. 2015;23(4):532–43.CrossRefPubMed Karsdal MA, et al. Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials. Osteoarthritis Cartilage. 2015;23(4):532–43.CrossRefPubMed
49.
go back to reference Arden NK, et al. The effect of vitamin D supplementation on knee osteoarthritis, the VIDEO study: a randomised controlled trial. Osteoarthritis Cartilage. 2016;24(11):1858–66.CrossRefPubMedPubMedCentral Arden NK, et al. The effect of vitamin D supplementation on knee osteoarthritis, the VIDEO study: a randomised controlled trial. Osteoarthritis Cartilage. 2016;24(11):1858–66.CrossRefPubMedPubMedCentral
50.
go back to reference Reginster JY, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial. Ann Rheum Dis. 2013;72(2):179–86.CrossRefPubMed Reginster JY, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial. Ann Rheum Dis. 2013;72(2):179–86.CrossRefPubMed
51.
go back to reference Fleischmann RM, et al. A phase II trial of lutikizumab, an anti-interleukin-1alpha/beta Dual variable domain immunoglobulin, in knee osteoarthritis patients with synovitis. Arthritis Rheumatol. 2019;71(7):1056–69.CrossRefPubMed Fleischmann RM, et al. A phase II trial of lutikizumab, an anti-interleukin-1alpha/beta Dual variable domain immunoglobulin, in knee osteoarthritis patients with synovitis. Arthritis Rheumatol. 2019;71(7):1056–69.CrossRefPubMed
52.
go back to reference Manno RL, et al. OARSI-OMERACT initiative: defining thresholds for symptomatic severity and structural changes in disease modifying osteoarthritis drug (DMOAD) clinical trials. Osteoarthritis Cartilage. 2012;20(2):93–101.CrossRefPubMed Manno RL, et al. OARSI-OMERACT initiative: defining thresholds for symptomatic severity and structural changes in disease modifying osteoarthritis drug (DMOAD) clinical trials. Osteoarthritis Cartilage. 2012;20(2):93–101.CrossRefPubMed
53.
go back to reference Hosmer DW Jr, Lemeshow S, Sturdivant RX. Applied logistic regression, vol. 398: John Wiley & Sons; 2013.CrossRef Hosmer DW Jr, Lemeshow S, Sturdivant RX. Applied logistic regression, vol. 398: John Wiley & Sons; 2013.CrossRef
54.
go back to reference Frank E, et al. Tutorial in biostatistics multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996;15:361–87.CrossRef Frank E, et al. Tutorial in biostatistics multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996;15:361–87.CrossRef
55.
go back to reference Hastie T, et al. The elements of statistical learning: data mining, inference, and prediction, vol. 2: Springer; 2009.CrossRef Hastie T, et al. The elements of statistical learning: data mining, inference, and prediction, vol. 2: Springer; 2009.CrossRef
56.
go back to reference Steyerberg EW, et al. Assessing the performance of prediction models: a framework for traditional and novel measures. Epidemiology. 2010;21(1):128–38.CrossRefPubMedPubMedCentral Steyerberg EW, et al. Assessing the performance of prediction models: a framework for traditional and novel measures. Epidemiology. 2010;21(1):128–38.CrossRefPubMedPubMedCentral
59.
go back to reference Abramson SB, et al. Introduction to OARSI FDA initiative OAC special edition. Osteoarthritis Cartilage. 2011;19(5):475–7.CrossRefPubMed Abramson SB, et al. Introduction to OARSI FDA initiative OAC special edition. Osteoarthritis Cartilage. 2011;19(5):475–7.CrossRefPubMed
61.
go back to reference Jordan JM, Henrotin Y. Osteoarthritis research society international initiative on recommendations for conducting clinical trials in osteoarthritis: overview. Osteoarthritis Cartilage. 2015;23(5):671–3.CrossRefPubMed Jordan JM, Henrotin Y. Osteoarthritis research society international initiative on recommendations for conducting clinical trials in osteoarthritis: overview. Osteoarthritis Cartilage. 2015;23(5):671–3.CrossRefPubMed
63.
go back to reference Kraus VB, et al. Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA’s accelerated approval regulations for disease modifying osteoarthritis drugs. Osteoarthritis Cartilage. 2019;27(4):571–9.CrossRefPubMed Kraus VB, et al. Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA’s accelerated approval regulations for disease modifying osteoarthritis drugs. Osteoarthritis Cartilage. 2019;27(4):571–9.CrossRefPubMed
64.
go back to reference Kim Y, et al. Concept end points informing design considerations for confirmatory clinical trials in osteoarthritis. Arthritis Care Res (Hoboken). 2022;74(7):1154–62.CrossRefPubMed Kim Y, et al. Concept end points informing design considerations for confirmatory clinical trials in osteoarthritis. Arthritis Care Res (Hoboken). 2022;74(7):1154–62.CrossRefPubMed
Metadata
Title
Biomarkers in osteoarthritis: current status and outlook — the FNIH Biomarkers Consortium PROGRESS OA study
Authors
David J. Hunter
Jamie E. Collins
Leticia Deveza
Steven C. Hoffmann
Virginia B. Kraus
Publication date
24-01-2023
Publisher
Springer Berlin Heidelberg
Published in
Skeletal Radiology / Issue 11/2023
Print ISSN: 0364-2348
Electronic ISSN: 1432-2161
DOI
https://doi.org/10.1007/s00256-023-04284-w

Other articles of this Issue 11/2023

Skeletal Radiology 11/2023 Go to the issue