Design and conduct of clinical trials in patients with osteoarthritis: Recommendations from a task force of the Osteoarthritis Research Society

Altman, Roy D.; Brandt, Kenneth D.; Hochberg, Marc C.; Moskowitz, Roland W.; Bellamy, Nicholas; Blöch, D.; Buckwalter, Joseph A.; Dougados, Maxime; Ehrlich, George E.; Lequesne, M; Lohmander, Stefan; Murphy, William A.; Rosario-Jansen, Theresa; Schwartz, Benjamin D.; Trippel, Stephen B.

doi:10.1016/s1063-4584(05)80101-3

Cited by 507 publications

(347 citation statements)

References 56 publications

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“…Based on limited preliminary evidence, it has therefore been suggested that a number of drugs, including glucosamine and CS, should be formally tested for their disease-modifying properties (11). The main evaluation criterion for disease-modifying drugs is the prospective evaluation of radiographic changes by analysis of joint space narrowing (12,13).…”

Section: Discussionmentioning

confidence: 99%

“…Exclusion criteria were as follows: the presence of any causes of secondary OA including calcium pyrophosphate deposition disease (12); traumatic knee lesions; severe comorbidity (specifically, severe renal, heart, lung, or neurologic disease); previous joint surgery; intraarticular medications, including corticosteroids, in the past month; and the foreseeable prospect of major surgery during the 2-year study period. For potentially longer-acting substances such as CS and glucosamine, a washout period of 3 months was required.…”

Section: Methodsmentioning

confidence: 99%

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Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: A randomized, controlled trial

Michel

Stucki²,

Frey

et al. 2005

Arthritis & Rheumatism

250

171

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Objective. To determine whether chondroitin sulfate (CS) is effective in inhibiting cartilage loss in knee osteoarthritis (OA).Methods. In this randomized, double-blind, placebo-controlled trial, 300 patients with knee OA were recruited from an outpatient clinic, from private practices, and through advertisements. Study patients were randomly assigned to receive either 800 mg CS or placebo once daily for 2 years. The primary outcome was joint space loss over 2 years as assessed by a posteroanterior radiograph of the knee in flexion; secondary outcomes included pain and function.Results. Of 341 patients screened, 300 entered the study and were included in the intent-to-treat analysis. The 150 patients receiving placebo had progressive joint space narrowing, with a mean ؎ SD joint space loss of 0.14 ؎ 0.61 mm after 2 years (P ‫؍‬ 0.001 compared with baseline). In contrast, there was no change in mean joint space width for the 150 patients receiving CS (0.00 ؎ 0.53 mm; P not significant compared with baseline). Similar results were found for minimum joint space narrowing. The differences in loss of joint space between the two groups were significant for mean joint space width (0.14 ؎ 0.57 mm; P ‫؍‬ 0.04) and for minimum joint space width (0.12 ؎ 0.52 mm; P ‫؍‬ 0.05). CS was well tolerated, with no significant differences in rates of adverse events between the two groups. Conclusion.While there was no significant symptomatic effect in this study, long-term treatment with CS may retard radiographic progression in patients with OA of the knee. However, the clinical relevance of the observed structural results has to be further evaluated, and further studies are needed to confirm the structural effects of CS.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: A randomized, controlled trial

Michel

Stucki²,

Frey

et al. 2005

Arthritis & Rheumatism

250

171

View full text Add to dashboard Cite

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“…prior to the clinical evaluation, which may partly explain the apparent lack of correlation between the clinical and the cartilage volume findings. A washout period for analgesic/ antiinflammatory medication is now a standard procedure requested by the regulatory agencies for studies assessing drugs that may affect OA progression clinically as well as structurally (64).…”

Section: Discussionmentioning

confidence: 99%

Quantitative magnetic resonance imaging evaluation of knee osteoarthritis progression over two years and correlation with clinical symptoms and radiologic changes

Raynauld¹,

Martel‐Pelletier²,

Berthiaume³

et al. 2004

Arthritis & Rheumatism

Self Cite

239

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Objective. To evaluate the change in osteoarthritic (OA) knee cartilage volume over a two-year period with the use of magnetic resonance imaging (MRI) and to correlate the MRI changes with radiologic changes.Methods. Thirty-two patients with symptomatic knee OA underwent MRI of the knee at baseline and at 6, 12, 18, and 24 months. Loss of cartilage volumes were computed and contrasted with changes in clinical variables for OA and with standardized semiflexed knee radiographs at baseline at 1 and 2 years.Results. Progression of cartilage loss at all followup points was statistically significant (P < 0.0001), with a mean ؎ SD of 3.8 ؎ 5.1% for global cartilage loss and 4.3 ؎ 6.5% for medial compartment cartilage loss at 6 months, 3.6 ؎ 5.1% and 4.2 ؎ 7.5% at 12 months, and 6.1 ؎ 7.2% and 7.6 ؎ 8.6% at 24 months. Discriminant function analysis identified 2 groups of patients, those who progressed slowly (<2% of global cartilage loss; n ‫؍‬ 21) and those who progressed rapidly (>15% of global cartilage loss; n ‫؍‬ 11) over the 2 years of study. At baseline, there was a greater proportion of women (P ‫؍‬ 0.001), a lower range of motion (P ‫؍‬ 0.01), a greater circumference and higher level of pain (P ‫؍‬ 0.05) and stiffness in the study knee, and a higher body mass index in the fast progressor group compared with the slow progressor group. No statistical correlation between loss of cartilage volume and radiographic changes was seen.Conclusion. Quantitative MRI can measure the progression of knee OA precisely and can help to identify patients with rapidly progressing disease. These findings indicate that MRI could be helpful in assessing the effects of treatment with structure-modifying agents in OA.In people over the age of 60 years, osteoarthritis (OA) is a common cause of disability. Assessment of cartilage damage is important for monitoring disease progression and evaluating therapeutic response in OA. For many years, clinical studies of drug interventions in symptomatic knee OA have focused specifically on clinical parameters, such as pain and joint function, without assessing the effect of treatment on structural changes caused by the disease or the role of treatment in preventing cartilage degradation. Serial radiographs of affected joints appear to be a logical means of documenting the progression of OA over time (1), provided that a validated, reliable, and easily reproducible technique is used (2-5).

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“…To cover multiple aspects in the assessment of patients (Paper I), the use of both disease-specifi c and generic questionnaires is recommended (Small et al 1994, Hawker et al 1995, Altman et al 1996.…”

Section: Short-form 36-item Health Surveymentioning

confidence: 99%

Meniscal tear - a feature of osteoarthritis

Englund¹

2004

SORT

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Meniscectomy is recognized as an important risk factor for the development of knee osteoarthritis (OA), a disease that traditionally has been considered as a simple "wear and tear" phenomenon. However, despite numerous reports, little evidence has been presented that a limited meniscal resection, compared with a more extensive resection, reduces the risk of OA by preserving meniscal function. Why? This thesis provides one possible answer to that question.Patients, who had undergone isolated meniscal resection in 1973, 1978, or between 1983 and 1985 at Lund University Hospital, Sweden, were reviewed clinically and radiographically 15-22 years after the surgical procedure.Of the subjects (n = 317) almost 50% had developed radiographic OA in their operated knee, but just over half of these patients were symptomatic. An additional 20% of the patients had knee symptoms, but did not have radiographic knee OA. These results confi rm a limited correlation between radiographic features of the disorder and symptoms.A degenerative type of meniscal tear and obesity were the factors most strongly associated with both radiographic knee OA and symptomatic radiographic knee OA.Partial meniscal resection induced less radiographic changes related to knee OA compared with total meniscectomy, but the patient-relevant outcomes remained essentially the same.If radiographic hand OA was present there was an increased likelihood of the patient also having knee OA following meniscectomy. This fi nding was independent of age, and therefore an inherited susceptibility to the disease contributes to the risk of knee OA after meniscal tear. Genetic and environmental risk factors interact in OA development.A degenerative meniscal lesion is often associated with early-stage knee OA, a disorder also involving the meniscal tissue. The tear may thus represent the fi rst "signal" feature of OA. The challenge for the health professional is to discriminate between symptoms caused by a meniscal tear and those caused by OA. Meniscal resection may not benefi t the patient with early-stage knee OA. The intervention merely removes evidence of the disorder, while the OA joint degradation proceeds.

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Design and conduct of clinical trials in patients with osteoarthritis: Recommendations from a task force of the Osteoarthritis Research Society

Cited by 507 publications

References 56 publications

Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: A randomized, controlled trial

Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: A randomized, controlled trial

Quantitative magnetic resonance imaging evaluation of knee osteoarthritis progression over two years and correlation with clinical symptoms and radiologic changes

Meniscal tear - a feature of osteoarthritis

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