Experience with a Placebo-Controlled Randomized Clinical Trial of a Disease-Modifying Drug for Osteoarthritis: The Doxycycline Trial

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The doxycycline trial

This article describes the results of a recent randomized placebo-controlled trial (RCT) designed to examine the DMOAD effect in humans of the tetracycline antibiotic doxycycline (doxy), and reviews the experience gained from other recent DMOAD trials in humans. The details of the doxy RCT are published elsewhere [4].

Caveats and conclusions

The subjects in the doxy study were homogeneous with respect to sex, BMI, age, and discordance in the severity of OA disease in their two knees, limiting the generalizability of these results. One cannot assume that the protective effect of doxy noted in the index knee would occur at other joint sites (eg, hips, hands), in subjects of all age groups, or in men. Furthermore, given the higher rate of adverse reactions in the doxy group than in the placebo group, the subjects may not have been

Acknowledgments

Data for the doxycycline trial were collected at six clinical research centers: Indiana University Medical Center (John D. Bradley, MD, and Steven T. Hugenberg, MD), the Arthritis Research Foundation (Frederick Wolfe, MD), University of Pittsburgh (Susan Manzi, MD, and Chester V. Oddis, MD), University of Alabama at Birmingham (Larry W. Moreland, MD, and Louis W. Heck, MD), Northwestern University Center for Clinical Research (Thomas J. Schnitzer, MD, and Leena Sharma, MD), and University of

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    Supported in part by National Institutes of Health Grants R01 AR43348, P60 AR20582, and R01 AR44370.

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