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Article History

Received: 6 November 2022

Accepted: 11 January 2023

First Online: 28 January 2023

Declarations

:

: Masataka Shiraki and Hiroaki Ohta declare no conflict of interest (COI). Yukari Uemura has received a consultancy fee from Teijin Pharma Ltd. and Daiichi Sankyo and outsourcing fees from Chugai Pharmaceutical Co. Teruki Sone has received research grants from Asahi Kasei Pharma Corp., Astellas Pharma, Taisho Toyama Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pizer, and Teijin Pharma Ltd., and consulting fees from Kissei pharmaceutical Co. Ltd., Shimadzu Corp., and Takeda Pharmaceutical Co. Ltd. Shiro Tanaka has received lecture fees from Bayer Yakuhin, Amgen Astellas BioPharma K.K. and Research Institute of Healthcare Data Science. He has received consultation fees from Boehringer Ingelheim. He has also received outsourcing fee from Public Health Research Foundation and Satt and grants from Novo Nordisk Pharma Ltd., the Japan Agency for Medical Research and Development, the Japanese Ministry of Health Labor and Welfare, and the Japanese Ministry of Education, Science, and Technology. He had engaged in a research project of the Japan Agency for Medical Research and Development. Satoshi Soen received lecture and consultancy fees from Asahi Kasei Pharma Corp., Astellas Pharma, Chugai Pharmaceutical Co., Daiichi Sankyo, Eisai Co. Ltd., Eli Lilly Japan, Ono Pharmaceutical Co., Pfizer, and Takeda Pharmaceutical Company Ltd. Satoshi Mori declares no COI. Hiroshi Hagino has received lecture fees or grants outside the submitted work from Amgen Inc., Asahi Kasei Pharma Corp., Astellas Pharma Inc., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan Co., Ltd., Mitsubishi Tanabe Pharma Corp., Mochida Pharma Corp., Ono Pharmaceutical Co., Ltd., Pizer Inc., Taisho Pharmaceutical Co., Ltd., Teijin Pharma Co., Ltd., and UCB Japan. Masao Fukunaga has received consulting fees from Asahi Kasei Pharma Corp and lecture fees from Daiichi Sankyo, MSD, and Chugai Pharmaceutical Co. Toshitaka Nakamura has received personal fees and others from Asahi Pharma, Teijin Pharma, Daiichi-Sankyo Pharma, UCB Pharma, AMGEN, ASTELAS, Chugai Pharma, and MERCK. Hajime Orimo declares no COI.

: This study was registered at the University Hospital Medical Information Network- Clinical Trials Registry (UMIN-CTR) under the identification number UMIN000005433; date: April 13, 2011. The protocol was approved by the Central Ethical Committee for Adequate Treatment of Osteoporosis group (Chairman Dr. Rikushi Morita) and was reviewed by the institutional review board of each participating institution. The trial was conducted in accordance with the principles of the Declaration of Helsinki.

: Written informed consent was obtained prior to patient enrollment after a thorough explanation of the trial objectives, duration, and procedures.