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Relationship Between Bone Mineral Density and Risk of Vertebral Fractures with Denosumab Treatment in Japanese Postmenopausal Women and Men with Osteoporosis.
Calcified Tissue International ( IF 4.2 ) Pub Date : 2020-08-25 , DOI: 10.1007/s00223-020-00750-y
Naoki Okubo 1 , Shigeyuki Matsui 2 , Toshio Matsumoto 3 , Toshitsugu Sugimoto 4 , Takayuki Hosoi 5 , Taisuke Osakabe 1 , Ko Watanabe 1 , Hideo Takami 1 , Masataka Shiraki 6 , Toshitaka Nakamura 7
Affiliation  

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.



中文翻译:

日本绝经后妇女和骨质疏松症男性的骨密度和椎间盘突出症风险与地诺单抗治疗之间的关系。

在对日本绝经后女性和骨质疏松男性患者进行的Denosumab骨折干预随机安慰剂对照试验(DIRECT)的事后分析中,我们评估了椎骨骨折风险与骨矿物质密度(BMD)T分数与术后骨百分比变化之间的关系。在整个髋部,股骨颈和腰椎进行denosumab治疗24个月。进行Logistic回归分析,并评估BMD解释的治疗效果在椎骨骨折风险中的比例。结果表明,总髋部BMD T分数和改变均可作为后续骨折风险的有力预测指标,并且总髋部BMD改变可解释73%的治疗效果,而T分数可解释23%的治疗效果。相反,股骨颈BMD改变和T值均不能预测denosumab对椎体骨折风险的影响。此外,尽管腰椎BMD T值与椎骨骨折发生率相关,但腰椎BMD变化与椎骨骨折风险成反比。由于地诺单抗治疗24个月时腰椎BMD变化与T评分之间没有关系,并且由于可能存在小的无法检测到的椎体畸形,可能会增加BMD值,因此这些结果表明,腰椎BMD变化并不是治疗BMD的好方法椎骨骨折风险评估。建议在denosumab治疗下的日本骨质疏松患者中,总髋骨BMD变化和T分数均可以很好地预测椎骨骨折的风险。尽管腰椎BMD T值与椎骨骨折发生率相关,但腰椎BMD变化与椎体骨折风险成反比。由于地诺单抗治疗24个月时腰椎BMD变化与T评分之间没有关系,并且由于可能存在小的无法检测到的椎体畸形,可能会增加BMD值,因此这些结果表明,腰椎BMD变化并不是治疗BMD的好方法椎骨骨折风险评估。建议在denosumab治疗下的日本骨质疏松患者中,总髋骨BMD变化和T分数均可以很好地预测椎骨骨折的风险。尽管腰椎BMD T值与椎骨骨折发生率相关,但腰椎BMD变化与椎体骨折风险成反比。由于地诺单抗治疗24个月时腰椎BMD变化与T评分之间没有关系,并且由于可能存在小的无法检测到的椎体畸形,可能会增加BMD值,因此这些结果表明,腰椎BMD变化并不是治疗BMD的好方法椎骨骨折风险评估。建议在denosumab治疗下的日本骨质疏松患者中,总髋骨BMD变化和T分数均可以很好地预测椎骨骨折的风险。由于地诺单抗治疗24个月时腰椎BMD变化与T评分之间没有关系,并且由于可能存在小的无法检测到的椎体畸形,可能会增加BMD值,因此这些结果表明,腰椎BMD变化并不是治疗BMD的好方法椎骨骨折风险评估。建议在denosumab治疗下的日本骨质疏松患者中,总髋骨BMD变化和T分数均可以很好地预测椎骨骨折的风险。由于地诺单抗治疗24个月时腰椎BMD变化与T评分之间没有关系,并且由于可能存在小的无法检测到的椎体畸形,可能会增加BMD值,因此这些结果表明,腰椎BMD变化并不是治疗BMD的好方法椎骨骨折风险评估。建议在denosumab治疗下的日本骨质疏松患者中,总髋骨BMD变化和T分数均可以很好地预测椎骨骨折的风险。

ClinicalTrials.gov标识符:NCT00680953。

更新日期:2020-08-25
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