Author Contributions: Mss Mackey and Lui had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Mackey, Cummings.
Acquisition of data: Cawthon, Bauer, Nevitt, Cauley, Hillier, Lewis, Barrett-Connor, Cummings.
Analysis and interpretation of data: Mackey, Lui, Cawthon, Bauer, Nevitt, Cummings.
Drafting of the manuscript: Mackey.
Critical revision of the manuscript for important intellectual content: Mackey, Lui, Cawthon, Bauer, Nevitt, Cauley, Hillier, Lewis, Barrett-Connor, Cummings.
Statistical analysis: Mackey, Lui, Cawthon.
Obtained funding: Bauer, Nevitt, Cauley, Hillier, Lewis, Barrett-Connor, Cummings.
Administrative, technical, or material support: Mackey, Cawthon, Bauer, Nevitt, Cummings.
Study supervision: Cummings.
Financial Disclosures: Dr Cawthon reported receiving research support from Amgen. Dr Bauer reported receiving research support from Amgen, Aventis, Novartis, and NPS Pharmaceuticals. Dr Nevitt reported receiving honoraria from Eli Lilly and Wyeth for osteoarthritis-related activities. Dr Cauley reported receiving research support from Eli Lilly, Merck, Novartis, and Pfizer; receiving consulting fees from Eli Lilly and Novartis; and serving on the speakers bureau for Merck. Dr Lewis reported receiving research support from Pfizer. Dr Barrett-Connor reported receiving research support from Amgen, Eli Lilly, GlaxoSmithKline, Merck, the National Institutes of Health, Procter & Gamble, Roche, and Wyeth. Dr Cummings reported receiving research support from Amgen, Eli Lilly, Novartis, Organon, and Pfizer and consulting fees or honoraria from Amgen, Aventis, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Kyphon, Merck, Novartis, Procter & Gamble, Roche, Tethys, and Zelos. No other disclosures were reported.
Funding/Support: The Study of Osteoporotic Fractures (SOF) is supported by Public Health Service research grants from the National Institutes of Health (AG05407, AR35582, AG05394, AR35584, AR35583, R01 AG005407, R01 AG027576-22, 2 R01 AG005394-22A1, and 2 R01 AG027574-22A1). The Osteoporotic Fractures in Men Study (MrOS) is supported by National Institutes of Health funding. The following institutes provide support: the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Cancer Institute, the National Center for Research Resources, and National Institutes of Health Roadmap for Medical Research under the following grant numbers: U01 AR45580, U01 AR45614, U01 AR45632, U01 AR45647, U01 AR45654, U01 AR45583, U01 AG18197, U01-AG027810, and UL1 RR024140.
Role of the Sponsors: The funding agencies had no direct role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, or approval of the manuscript.
Previous Presentations: Abstracts of results from the SOF were presented at the XXI Paulo Symposium on Preventing Bone Fragility and Fractures; May 7-9, 2006; Tampere, Finland; and at the 24th Annual Meeting of the American Society for Bone and Mineral Research; September 20-24, 2002; San Antonio, Texas. An abstract of results from the MrOS Study was presented at the 28th Annual Meeting of the American Society for Bone and Mineral Research; September 15-19, 2006; Philadelphia, Pennsylvania.