OP-1 Clinical Studies

Osteopontin-1 (OP-1) has demonstrated considerable clinical usefulness, along with a strong record of safety, in a wide variety of musculoskeletal disorders in more than 500 patients worldwide during the past decade. Specifically, the outcomes of patients with tibial nonunions enrolled in a randomized, prospective clinical trial in the United States and treated with OP-1 and intramedullary fixation were comparable with those of patients treated with bone autograft and a rod. These, and the other carefully observed cases, build on substantial preclinical evaluation and begin the very important and practical process of clarifying the unique role these molecules will play in the clinical arena. As with many new directions in medicine, the earliest research raises meaningful questions about study goals and design, including the specific questions to be addressed, the appropriateness and limitations of available methods of assessment, and the interpretation of data. The scope and the funding of clinical trials, as well as management of the partnership between academia and industry, are frequent issues encountered and addressed in the conduct of novel and cutting-edge …