Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenop
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ORIGINAL RESEARCH
Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis Naoki Okubo1 · Shigeyuki Matsui2 · Toshio Matsumoto3 · Toshitsugu Sugimoto4 · Takayuki Hosoi5 · Taisuke Osakabe1 · Ko Watanabe1 · Hideo Takami1 · Masataka Shiraki6 · Toshitaka Nakamura7 Received: 31 March 2020 / Accepted: 11 August 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract In this post hoc analysis of the Denosumab Fracture Intervention Randomized Placebo-Controlled Trial (DIRECT) in Japanese postmenopausal women and men with osteoporosis, we evaluated the relationship between vertebral fracture risk and both bone mineral density (BMD) T-score and percent change after 24 months of denosumab treatment at total hip, femoral neck, and lumbar spine. Logistic regression analysis was performed and the proportion of treatment effect explained by BMD in vertebral fracture risk was estimated. The results demonstrate that both total hip BMD T-score and change can be strong predictors of subsequent fracture risk, and that total hip BMD change explained 73%, while T-score explained 23%, of the treatment effect. In contrast, neither femoral neck BMD change nor T-score can predict the effect of denosumab on vertebral fracture risk. Furthermore, although lumbar spine BMD T-score was associated with vertebral fracture incidence, lumbar spine BMD change was inversely related to vertebral fracture risk. Because there was no relationship between lumbar spine BMD change and T-score at 24 months of denosumab treatment, and because there can be small undetectable vertebral deformities that may increase BMD values, these results suggest that lumbar spine BMD change is not a good surrogate for vertebral fracture risk assessment. It is suggested that both total hip BMD change and T-score can be good surrogates for predicting vertebral fracture risk in Japanese patients with osteoporosis under denosumab treatment. ClinicalTrials.gov identifier: NCT00680953. Keywords Denosumab · Bone mineral density (BMD) change · BMD T-score · Vertebral fracture risk · Osteoporosis
Introduction Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00223-020-00750-y) contains supplementary material, which is available to authorized users. * Naoki Okubo [email protected] 1
Daiichi Sankyo Co., Ltd., Tokyo, Japan
2
Nagoya University Graduate School of Medicine, Nagoya, Japan
3
Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan
4
Eikokai Ono Hospital, Hyogo, Japan
5
Kenkoin Clinic, Tokyo, Japan
6
Research Institute and Practice for Involutional Diseases, Nagano, Japan
7
Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan
Fractures are the main complication of osteoporosis and the goal of therapy is to reduce the fracture risk. Low bone mineral density (BMD) measured by
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