The Journal of Bone and Joint Surgery (American) 83:S160-160 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.
OP-1 Clinical Studies
Gary E. Friedlaender, MD
Department of Orthopaedic Surgery
Yale University School of Medicine
New Haven, CT 06520-8071
In support of his research or preparation of this manuscript, the
author received grants or outside funding from Stryker Biotech.
In addition, the author received payments or other benefits or a
commitment or agreement to provide such benefits from a commercial
entity (Stryker Biotech). No commercial entity paid or directed,
or agreed to pay or direct, any benefits to any research fund, foundation,
educational institution, or other charitable or nonprofit organization
with which the author is affiliated or associated.
| The first 150 words of the full text of this article appear below. |
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, . . . [Full Text of this Article]
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