Methodology of clinical trials in hand osteoarthritis. Issues and proposals.

Although very common, hand osteoarthritis has rarely been the focus of clinical trials aimed at determining whether old or new drugs are effective on its symptoms or anatomical course. In addition to the difficulties inherent to studies of osteoarthritis in general, the highly unpredictable course of hand osteoarthritis poses specific challenges. Hand osteoarthritis is only beginning to be considered a potentially useful model for therapeutic trials and clinical research, in addition to the two widely-used models, knee and hip osteoarthritis. Recent studies have provided new information on the clinical and roentgenographic course of hand osteoarthritis. An algofunctional index and a quantitative roentgenographic score have been developed and validated as tools for evaluating and monitoring hand osteoarthritis. These tools are now available for use during therapeutic trials. In this article, we will make a number of recommendations about the selection of patients and of quantitative evaluation methods. These recommendations take into account the specific features of hand osteoarthritis and of the various categories of drugs for osteoarthritis; they place special emphasis on the most recent drug classes, namely symptomatic slow-acting drugs for osteoarthritis and potentially "chondroprotective" agents.