We note Yu Zhang and Rongrui Tang's criticism of the use of a placebo control group in the original FREEDOM trial,¹ which was followed by a 7-year open-label extension, the subject of our Article. FREEDOM was initiated in 2004, was conducted in compliance with Food and Drug Administration and European Medicines Agency regulatory guidance,^2,3 and was reviewed and approved by the Ethics Committee or equivalent for every participating site. In addition, all participants were given calcium and vitamin D supplementation, and the protocol provided for discontinuation of study medication and initiation of appropriate treatment for participants who experienced an osteoporosis-related fracture or a significant decrease in bone mineral density.

中文翻译：

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绝经后骨质疏松症妇女的地诺单抗治疗-作者的回复

我们注意到Yu Zhang和Tang Rongrui Tang在最初的FREEDOM试验中对使用安慰剂对照组的批评，¹随后是7年的开放标签扩展，这是本文的主题。FREEDOM于2004年发起，遵循食品药品管理局和欧洲药品管理局的法规指南^2,3进行，并由道德委员会或每个参与站点的等效委员会进行了审查和批准。此外，所有参与者都接受了钙和维生素D的补充，并且该方案规定了对于经历骨质疏松症相关骨折或骨矿物质密度显着下降的参与者，应停止研究药物的治疗并开始适当的治疗。