The relationship between treatment-related changes in total hip BMD measured after 12, 18, and 24 mo and fracture risk reduction in osteoporosis clinical trials: the FNIH-ASBMR-SABRE project.

Autor:	Vilaca T; Division of Clinical Medicine, University of Sheffield, Sheffield S5 7AU, United Kingdom., Schini M; Division of Clinical Medicine, University of Sheffield, Sheffield S5 7AU, United Kingdom., Lui LY; Research Institute, California Pacific Medical Center, San Francisco, CA 94158, United States., Ewing SK; Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, CA 94158, United States., Thompson AR; Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, CA 94158, United States., Vittinghoff E; Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, CA 94158, United States., Bauer DC; Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, CA 94158, United States.; Department of Medicine, University of California at San Francisco, San Francisco, CA 94158, United States., Eastell R; Division of Clinical Medicine, University of Sheffield, Sheffield S5 7AU, United Kingdom., Black DM; Department of Epidemiology and Biostatistics, University of California at San Francisco, San Francisco, CA 94158, United States., Bouxsein ML; Center for Advanced Orthopedic Studies, Beth Israel Deaconess Medical Center and Department of Orthopedic Surgery, Harvard Medical School, Boston, MA 02215, United States.
Jazyk:	angličtina
Zdroj:	Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research [J Bone Miner Res] 2024 Sep 26; Vol. 39 (10), pp. 1434-1442.
DOI:	10.1093/jbmr/zjae126
Abstrakt:	There is a strong association between total hip bone mineral density (THBMD) changes after 24 mo of treatment and reduced fracture risk. We examined whether changes in THBMD after 12 and 18 mo of treatment are also associated with fracture risk reduction. We used individual patient data (n = 122 235 participants) from 22 randomized, placebo-controlled, double-blind trials of osteoporosis medications. We calculated the difference in mean percent change in THBMD (active-placebo) at 12, 18, and 24 mo using data available for each trial. We determined the treatment-related fracture reductions for the entire follow-up period, using logistic regression for radiologic vertebral fractures and Cox regression for hip, non-vertebral, "all" (combination of non-vertebral, clinical vertebral, and radiologic vertebral) fractures and all clinical fractures (combination of non-vertebral and clinical vertebral). We performed meta-regression to estimate the study-level association (r2 and 95% confidence interval) between treatment-related differences in THBMD changes for each BMD measurement interval and fracture risk reduction. The meta-regression revealed that for vertebral fractures, the r2 (95% confidence interval) was 0.59 (0.19, 0.75), 0.69 (0.32, 0.82), and 0.73 (0.33, 0.84) for 12, 18, and 24 mo, respectively. Similar patterns were observed for hip: r2 = 0.27 (0.00, 0.54), 0.39 (0.02, 0.63), and 0.41 (0.02, 0.65); non-vertebral: r2 = 0.27 (0.01, 0.52), 0.49 (0.10, 0.69), and 0.53 (0.11, 0.72); all fractures: r2 = 0.44 (0.10, 0.64), 0.63 (0.24, 0.77), and 0.66 (0.25, 0.80); and all clinical fractures: r2 = 0.46 (0.11, 0.65), 0.64 (0.26, 0.78), and 0.71 (0.32, 0.83), for 12-, 18-, and 24-mo changes in THBMD, respectively. These findings demonstrate that treatment-related THBMD changes at 12, 18, and 24 mo are associated with fracture risk reductions across trials. We conclude that BMD measurement intervals as short as 12 mo could be used to assess fracture efficacy, but the association is stronger with longer BMD measurement intervals. (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Society for Bone and Mineral Research.)
Databáze:	MEDLINE
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