Unresolved questions in rheumatology: Motion for debate: Osteoarthritis clinical trials have not identified efficacious therapies because traditional imagingoutcome measures are inadequate

Arthritis and Rheumatism

Volumn 65, Issue 11, 2013, Pages 2748-2758

  Guermazi, Ali ^a   Roemer, Frank W ^b   Felson, David T ^a   Brandt, Kenneth D ^c  

^a BOSTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF KANSAS MEDICAL CENTER   (United States)

^c UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; ANTIRHEUMATIC AGENT;

BONE RADIOGRAPHY; CLINICAL TRIAL (TOPIC); DISEASE SEVERITY; FOOD AND DRUG ADMINISTRATION; HUMAN; KNEE OSTEOARTHRITIS; NOTE; NUCLEAR MAGNETIC RESONANCE IMAGING; PRIORITY JOURNAL; ARTHROGRAPHY; DISEASE COURSE; OSTEOARTHRITIS, KNEE; OUTCOME ASSESSMENT; PATHOLOGY; RADIOGRAPHY; STANDARDS; ARTICLE; STANDARD;

ANTIRHEUMATIC AGENTS; ARTHROGRAPHY; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; HUMANS; MAGNETIC RESONANCE IMAGING; OSTEOARTHRITIS, KNEE; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 84886791856     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.38086     Document Type: Note

References (66)

1. Hellio Le Graverand MP, Clemmer R, Redifer P, Brunell R, Hayes CW, Brandt K, et al. A 2-year randomized, double-blind, placebo-controlled, multicenter study of oral selective iNOS inhibitor, cindunistat, in patients with symptomatic osteoarthritis of the knee [abstract]. Presented at the 6th International Workshop on Osteoarthritis Imaging combined with the OARSI OA Biomarkers Workshop III-Imaging Biomarker Validation and Qualification; 2012 July 12-14; Hilton Head, SC.
2. Karsdal MA, Alexandersen P, John MR, Loeffler J, Arnold M, Azria M, et al. Oral calcitonin demonstrated symptom-modifying efficacy and increased cartilage volume: results from a 2-year phase 3 trial in patients with osteoarthritis of the knee [abstract]. Osteoarthritis Cartilage 2011; 19 Suppl 1: S35.
3. Kellgren JH, Lawrence JS,. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957; 16: 494-501.
4. Guermazi A, Niu J, Hayashi D, Roemer FW, Englund M, Neogi T, et al. Prevalence of abnormalities in knees detected by MRI in adults without knee osteoarthritis: population based observational study (Framingham Osteoarthritis Study). BMJ 2012; 345: e5339.
5. Yusuf E, Kortekaas MC, Watt I, Huizinga TW, Kloppenburg M,. Do knee abnormalities visualised on MRI explain knee pain in knee osteoarthritis? A systematic review. Ann Rheum Dis 2011; 70: 60-7.
6. Bijlsma JW, Berenbaum F, Lafeber FP,. Osteoarthritis: an update with relevance for clinical practice. Lancet 2011; 377: 2115-26.
7. Roemer FW, Guermazi A, Niu J, Zhang Y, Mohr A, Felson DT,. Prevalence of magnetic resonance imaging-defined atrophic and hypertrophic phenotypes of knee osteoarthritis in a population-based cohort. Arthritis Rheum 2012; 64: 429-37.
8. Nelson AE, Renner JB, Schwartz TA, Kraus VB, Helmick CG, Jordan JM,. Differences in multijoint radiographic osteoarthritis phenotypes among African Americans and Caucasians: the Johnston County Osteoarthritis Project. Arthritis Rheum 2011; 63: 3843-52.
9. Conaghan PG, Hunter DJ, Maillefert JF, Reichmann WM, Losina E,. Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group. Osteoarthritis Cartilage 2011; 19: 606-10.
10. Javaid MK, Lynch JA, Tolstykh I, Guermazi A, Roemer F, Aliabadi P, et al. Pre-radiographic MRI findings are associated with onset of knee symptoms: the MOST study. Osteoarthritis Cartilage 2010; 18: 323-8.
11. Amin S, LaValley MP, Guermazi A, Grigoryan M, Hunter DJ, Clancy M, et al. The relationship between cartilage loss on magnetic resonance imaging and radiographic progression in men and women with knee osteoarthritis. Arthritis Rheum 2005; 52: 3152-9.
12. Felson D, Niu J, Sack B, Aliabadi P, McCullough C, Nevitt MC,. Progression of osteoarthritis as a state of inertia. Ann Rheum Dis 2012. E-pub ahead of print.
13. Hunter DJ, Zhang YQ, Tu X, LaValley M, Niu JB, Amin S, et al. Change in joint space width: hyaline articular cartilage loss or alteration in meniscus? Arthritis Rheum 2006; 54: 2488-95.
14. Adams JG, McAlindon T, Dimasi M, Carey J, Eustace S,. Contribution of meniscal extrusion and cartilage loss to joint space narrowing in osteoarthritis. Clin Radiol 1999; 54: 502-6.
15. Kinds MB, Vincken KL, Hoppinga TN, Bleys RL, Viergever MA, Marijnissen AC, et al. Influence of variation in semiflexed knee positioning during image acquisition on separate quantitative radiographic parameters of osteoarthritis, measured by Knee Images Digital Analysis. Osteoarthritis Cartilage 2012; 20: 997-1003.
16. Englund M, Roemer FW, Hayashi D, Crema MD, Guermazi A,. Meniscus pathology, osteoarthritis and the treatment controversy. Nat Rev Rheumatol 2012; 8: 412-9.
17. Roemer FW, Zhang Y, Niu J, Lynch JA, Crema MD, Marra MD, et al, Multicenter Osteoarthritis Study Investigators. Tibiofemoral joint osteoarthritis: risk factors for MR-depicted fast cartilage loss over a 30-month period in the multicenter osteoarthritis study. Radiology 2009; 252: 772-80.
18. Roemer FW, Kwoh CK, Hannon MJ, Green SM, Jakicic JM, Boudreau R, et al. Risk factors for magnetic resonance imaging-detected patellofemoral and tibiofemoral cartilage loss during a six-month period: the Joints On Glucosamine study. Arthritis Rheum 2012; 64: 1888-98.
19. Saris DB, Vanlauwe J, Victor J, Almqvist KF, Verdonk R, Bellemans J, et al. Treatment of symptomatic cartilage defects of the knee: characterized chondrocyte implantation results in better clinical outcome at 36 months in a randomized trial compared to microfracture. Am J Sports Med 2009; 37 Suppl 1: 10S-19S.
20. Wildi LM, Raynauld JP, Martel-Pelletier J, Beaulieu A, Bessette L, Morin F, et al. Chondroitin sulphate reduces both cartilage volume loss and bone marrow lesions in knee osteoarthritis patients starting as early as 6 months after initiation of therapy: a randomised, double-blind, placebo-controlled pilot study using MRI. Ann Rheum Dis 2011; 70: 982-9.
21. McAlindon TE, Nuite M, Krishnan N, Ruthazer R, Price LL, Burstein D, et al. Change in knee osteoarthritis cartilage detected by delayed gadolinium enhanced magnetic resonance imaging following treatment with collagen hydrolysate: a pilot randomized controlled trial. Osteoarthritis Cartilage 2011; 19: 399-405.
22. Zhang Y, Nevitt M, Niu J, Lewis C, Torner J, Guermazi A, et al. Fluctuation of knee pain and changes in bone marrow lesions, effusions, and synovitis on magnetic resonance imaging. Arthritis Rheum 2011; 63: 691-9.
23. Roemer FW, Nevitt MC, Felson DT, Niu J, Lynch JA, Crema MD, et al. Predictive validity of within-grade scoring of longitudinal changes of MRI-based cartilage morphology and bone marrow lesion assessment in the tibio-femoral joint-the MOST Study. Osteoarthritis Cartilage 2012; 20: 1391-8.
24. Driban JB, Lo GH, Lee JY, Ward RJ, Miller E, Pang J, et al. Quantitative bone marrow lesion size in osteoarthritic knees correlates with cartilage damage and predicts longitudinal cartilage loss. BMC Musculoskelet Disord 2011; 12: 217.
25. Laslett LL, Dore DA, Quinn SJ, Boon P, Ryan E, Winzenberg TM, et al. Zoledronic acid reduces knee pain and bone marrow lesions over 1 year: a randomised controlled trial. Ann Rheum Dis 2012; 71: 1322-8.
26. Guermazi A, Roemer FW, Hayashi D, Crema MD, Niu J, Zhang Y, et al. Assessment of synovitis with contrast-enhanced MRI using a whole-joint semiquantitative scoring system in people with, or at high risk of, knee osteoarthritis: the MOST study. Ann Rheum Dis 2011; 70: 805-11.
27. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Reichmann WM, et al. Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence. Osteoarthritis Cartilage 2011; 19: 589-605.
28. US Food and Drug Administration. Guidance for industry:clinical development programs for drugs, devices, and biological products intended for the treatment of osteoarthritis. URL: http://fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071577.pdf.
29. Le Graverand MP, Buck RJ, Wyman BT, Vignon E, Mazzuca SA, Brandt KD, et al. Change in regional cartilage morphology and joint space width in osteoarthritis participants versus healthy controls: a multicentre study using 3.0 Tesla MRI and Lyon-Schuss radiography. Ann Rheum Dis 2010; 69: 155-62.
30. Wirth W, Duryea J, Hellio Le Graverand MP, John MR, Nevitt M, Buck RJ, et al for the OA Initiative Investigators Group. Direct comparison of fixed flexion radiography and MRI in knee osteoarthritis: responsiveness data from the Osteoarthritis Initiative. Osteoarthritis Cartilage 2013; 21: 117-25.
31. Raynauld JP, Martel-Pelletier J, Bias P, Laufer S, Haraoui B, Choquette D, et al, and the Canadian Licofene Study Group. Protective effects of licofelone, a 5-lipoxygenase and cyclo-oxygenase inhibitor, versus naproxen on cartilage loss in knee osteoarthritis: a first multicentre clinical trial using quantitative MRI. Ann Rheum Dis 2009; 68: 938-47.
32. Hellio Le Graverand MP, Mazzuca S, Duryea J, Brett A,. Radiographic-based grading methods and radiographic measurement of joint space width in osteoarthritis. Radiol Clin North Am 2009; 47: 567-79.
33. Crema MD, Nogueira-Barbosa MH, Roemer FW, Marra MD, Niu J, Chagas-Neto FA, et al. Three-dimensional turbo spin-echo magnetic resonance imaging (MRI) and semiquantitative assessment of knee osteoarthritis: comparison with two-dimensional routine MRI. Osteoarthritis Cartilage 2013; 21: 428-33.
34. Reginster JY, Badurski J, Bellamy N, Bensen W, Chapurlat R, Chevalier X, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomized placebo-controlled trial. Ann Rheum Dis 2013; 72: 179-86.
35. Felson DT, Parkes MJ, Marjanovic EJ, Callaghan M, Gait A, Cootes T, et al. Bone marrow lesions in knee osteoarthritis change in 6-12 weeks. Osteoarthritis Cartilage 2012; 20: 1514-8.
36. Garnero P, Peterfy C, Zaim S, Schoenharting M,. Bone marrow abnormalities on magnetic resonance imaging are associated with type II collagen degradation in knee osteoarthritis: a three-month longitudinal study. Arthritis Rheum 2005; 52: 2822-9.
37. Kellgren JH, Lawrence JS,. Radiological assessment of osteo-arthrosis. Ann Rheum Dis 1957; 16: 494-501.
38. Le Graverand MP, Buck RJ, Wyman BT, Vignon E, Mazzuca SA, Brandt KD, et al. Change in regional cartilage morphology and joint space width in osteoarthritis participants versus healthy controls: a multicentre study using 3.0 Tesla MRI and Lyon-Schuss radiography. Ann Rheum Dis 2010; 69: 155-62.
39. Adams JG, McAlindon T, Dimasi M, Carey J, Eustace S,. Contribution of meniscal extrusion and cartilage loss to joint space narrowing in osteoarthritis. Clin Radiol 1999; 54: 502-6.
40. Brandt KD, Dieppe P, Radin E,. Etiopathogenesis of osteoarthritis. Med Clin North Am 2009; 93: 1-24, xv.
41. Le Graverand MP, Vignon E, Brandt KD, Mazzuca SA, Piperno M, Buck R, et al. Head-to-head comparison of the Lyon Sschuss and fixed flexion radiographic techniques: long-term reproducibility in normal knees and sensitivity to change in osteoarthritic knees. Ann Rheum Dis 2008; 67: 1562-6.
42. Vignon E, Brandt K, Mercier C, Hochberg M, Hunter D, Mazzuca S, et al. Alignment of the medial tibial plateau affects the rate of joint space narrowing in the osteoarthritic knee. Osteoarthritis Cartilage 2010: 18: 1436-40.
43. Mercier C, Piperno M, Vignon E, Brandt K, Hochberg M, Hellio Le Graverand MP,. In normal knees, joint space width (JSW) is correlated with the intermargin distance (IMD), a measure of medial tibial plateau alignment: variations in IMD explain variability in JSW in serial radiographs. Joint Bone Spine 2013; 80: 183-7.
44. Brandt KD, Radin EL, Dieppe PA, van de Putte L,. The futility of current approaches to chondroprotection-a different perspective: comment on the article by Felson and Kim [letter]. Arthritis Rheum 2007; 56: 3873-4.
45. Radin EL, Burr DB,. Joints can heal. Semin Arthritis Rheum 1984; 13: 293-8.
46. Brandt KD, Dieppe P, Radin EL,. Commentary: Is it useful to subset "primary" osteoarthritis? A critique based on the evidence regarding the etiopathogenesis of osteoarthritis. Semin Arthritis Rheum 2009; 39: 81-95.
47. Andriacchi TP,. Dynamics of knee malalignment. Orthop Clin North Am 1994; 25: 395-403.
48. Sharma L, Dunlop DD, Cahue S, Song J, Hayes KW,. Quadriceps strength and osteoarthritis progression in malaligned and lax knees. Ann Intern Med 2003; 138: 613-9.
49. Miyazaki T, Wada M, Kawahara H, Sato M, Baba H, Shimada S,. Dynamic load at baseline can predict radiographic disease progression in medial compartment knee osteoarthritis. Ann Rheum Dis 2002; 61: 617-22.
50. Amin S, Luepongsak N, McGibbon CA, LaValley MP, Krebs DE, Felson DT,. Knee adduction moment and development of chronic knee pain in elders. Arthritis Rheum 2004; 51: 371-6.
51. Chang A, Hurwitz D, Dunlop D, Song J, Cahue S, Hayes K, et al. The relationship between toe-out angle during gait and progression of medial tibiofemoral osteoarthritis. Ann Rheum Dis 2007; 66: 1271-5.
52. Bullough PG, Goodfellow JW, O'Connor JJ,. The relationship between degenerative changes and load-bearing in the human hip. J Bone Joint Surg Br 1973; 55-B: 746-58.
53. Intema F, van Roermund PM, Castelein RM, Bijlsma JW, Lafeber FP,. Joint distraction in the treatment of severe knee osteoarthritis: the first clinical results [abstract]. Osteoarthritis Cartilage 2007; 15 Suppl C: C234.
54. Lafeber FP, Intema F, van Roermund PM, Marijnissen AC,. Unloading joints to treat osteoarthritis. Curr Opin Rheumatol 2006; 18: 519-25.
55. Marijnissen AC, van Roermund PM, van Melkebeek J, Schenk W, Verbout AJ, Bijlsma JW, et al. Clinical benefit of joint distraction in the treatment of severe osteoarthritis of the ankle: proof of concept in an open prospective study and in a randomized controlled study. Arthritis Rheum 2002; 46: 2893-902.
56. Pauwels F,. Biomechanics of the normal and diseased hip: theoretical foundation, technique and results of treatment-an atlas. New York: Springer-Verlag; 1976.
57. Maquet PG,. Biomechanics of the knee: with application to the pathogenesis and the surgical treatment of osteoarthritis. 2nd ed. New York: Springer-Verlag; 1984.
58. Hellio Le Graverand-Gastineau MP,. OA clinical trials: current targets and trials for OA. Choosing molecular targets: what have we learned and where are we headed? [review]. Osteoarthritis Cartilage 2009; 17: 1393-1401.
59. Brandt KD, Mazzuca SA, Katz BP, Lane KA, Buckwalter KA, Yocum DE, et al. Effect of doxycycline on progression of osteoarthritis: result of a randomized, placebo-controlled, double-blind trial. Arthritis Rheum 2005; 52: 2015-25.
60. Mazzuca SA, Brandt KD, German C, Buckwalter KA, Lane KA, Katz BP,. Development of radiographic changes of osteoarthritis in the "Chingford knee" reflects progression of disease or non-standardized positioning of the joint, rather than incident disease. Ann Rheum Dis 2003; 62: 1061-5.
61. Sawitzke AD, Shi H, Finco MF, Dunlop DD, Bingham CO III, Harris CL, et al. The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: a report from the Glucosamine/Chondroitin Arthritis Intervention Trial. Arthritis Rheum 2008; 58: 3183-91.
62. Brandt KD, Mazzuca SA, Katz BP,. Methodology and statistical analysis in the Glucosamine/Chondroitin Arthritis Intervention Trial: comment on the article by Sawitzke et al [letter]. Arthritis Rheum 2009; 60: 3514-5.
63. Raynauld JP, Martel-Pelletier J, Bias P, Laufer S, Haraoui B, Choquette D, et al, and the Canadian Licofene Study Group. Protective effects of licofelone, a 5-lipoxygenase and cyclo-oxygenase inhibitor, versus naproxen on cartilage loss in knee osteoarthritis: a first multicentre clinical trial using quantitative MRI. Ann Rheum Dis 2009; 68: 938-47.
64. Reginster JY, Badurski J, Bellamy N, Bensen W, Chapurlat R, Chevalier X, et al. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomized placebo-controlled trial. Ann Rheum Dis 2013; 72: 179-86.
65. Cooper C, Reginster JY, Chapurlat R, Christiansen C, Genant H, Bellamy N, et al. Efficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of a randomized double-blind placebo-controlled trial. Curr Med Res Opin 2012; 28: 231-9.
66. Liang MH,. Pushing the limits of patient-oriented outcome measurements in the search for disease modifying treatments for osteoarthritis. J Rheumatol Suppl 2004; 70: 61-5.