Author Contributions: Dr McAlindon had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr LaValley and Ms Price performed and are responsible for the statistical analyses for this study.
Study concept and design: McAlindon, LaValley, Nuite, Dawson-Hughes.
Acquisition of data: McAlindon, Schneider, Nuite, Lee, Lo, Dawson-Hughes.
Analysis and interpretation of data: McAlindon, LaValley, Schneider, Price, Lo, Dawson-Hughes.
Drafting of the manuscript: McAlindon, LaValley, Schneider, Nuite, Lee, Price.
Critical revision of the manuscript for important intellectual content: McAlindon, LaValley, Price, Lo, Dawson-Hughes.
Statistical analysis: McAlindon, LaValley, Price, Lo, Dawson-Hughes.
Obtained funding: McAlindon.
Administrative, technical, or material support: McAlindon, Schneider, Nuite, Lee.
Study supervision: McAlindon, Schneider, Lo, Dawson-Hughes.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr McAlindon reported that he serves as a consultant for Flexion, Bioberica, and sanofi-aventis; is a board member of Osteoarthritis Research Society International; and has a patent for conducting clinical trials over the Internet, dividends for which are paid to the University of Florida. Dr LaValley reported that he serves as a consultant for Sunovian Pharmaceuticals and is an associate editor of Arthritis Care & Research. Dr Schneider reported that she serves as a consultant to ImageIQ, Merck, Johnson & Johnson, and the National Institutes of Health; owns stock in Pfizer and General Electric; and is founder of NitroSci Pharmaceuticals. No other financial disclosures were reported.
Funding/Support: This study was funded by grant R01 AR51361 from the National Institutes of Health, NIAMS, and the Office of Dietary Supplements, grant UL1RR025752 from the National Center for Research Resources, and grant HFP90-020 from the Houston Veterans Affairs Health Services Research and Development Service.
Role of the Sponsor: The funding sponsors played no part in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Sponsors had no access to the data and did not perform any of the study analysis.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health or the Department of Veterans Affairs.
Online-Only Material: The Author Video Interview is available here.
Additional Contributions: We thank the participants who made this study possible. We also thank the following professionals for their uncompensated help with this study: Gayle Lester, PhD, of NIAMS, for guidance and advice; Arthur Rabson, MD, for surveillance of safety laboratory test monitoring, and Cheryl Garganta, MD, PhD, for plasma vitamin D analyses, both of the Tufts Medical Center; Eric Miller, PhD, Tufts University School of Engineering, for image analysis advice; Jeff Duryea, PhD, Brigham and Women's Hospital, for radiographic measurements; and the data and safety monitoring board for assistance with and oversight of this trial. The MRIs were performed under a contract by Longwood MRI.