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 eff ective on its symptoms or anatomical course. In addition to the diffic ulties inherent to studies of osteoarthritis in general, the highly un predictable course of hand osteoarthritis poses specific challenges. H and osteoarthritis is only beginning to be considered a potentially us eful model for therapeutic trials and clinical research, in addition t o the two widely-used models, knee and hip osteoarthritis. Recent stud ies have provided new information on the clinical and roentgenographic course of hand osteoarthritis. An algofunctional index and a quantita tive roentgenographic score have been developed and validated as tools for evaluating and monitoring hand osteoarthritis. These tools are no w available for use during therapeutic trials. In this article, we wil l make a number of recommendations about the selection of patients and of quantitative evaluation methods. These recommendations take into a ccount the specific features of hand osteoarthritis and of the various categories of drugs for osteoarthritis; they place special emphasis o n the most recent drug classes, namely symptomatic slow-acting drugs f or osteoarthritis and potentially ''chondroprotective'' agents.