Abstract
Introduction
Despite advances in drug treatment, the optimal treatment strategy for severe osteoporosis remains uncertain.
Materials and methods
This article reports the design and rationale for the Japanese Osteoporosis Intervention Trial-05 (JOINT-05), a randomized, controlled trial that compares the efficacy and safety of teriparatide followed by alendronate with alendronate monotherapy for severe osteoporosis.
Results
Postmenopausal women aged at least 75 years were eligible for the study if they were at high risk of fracture. Patients were recruited from 113 institutions in Japan between October 2014 and December 2017. They were randomly assigned in a 1:1 ratio to the sequential therapy arm (once-weekly subcutaneous injections of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy arm (alendronate for 120 weeks). The regimens for alendronate are 5 mg (orally administered once daily), 35 mg (orally administered once weekly), or 900 μg (intravenously administered once every 4 weeks). The primary endpoint is the incidence of morphometric vertebral fracture at 72 weeks. The secondary endpoints include the incidence of morphometric vertebral fracture at 120 weeks; incidence of morphometric vertebral or non-vertebral fractures at 72 and 120 weeks; incidence of clinical vertebral fracture at 72 and 120 weeks; changes in bone mineral density, quality of life scores (EuroQol 5 Dimensions and the Japanese Osteoporosis Quality of Life Questionnaire short form), and a visual analog scale for back pain; and adverse events.
Conclusion
We reported the design and rationale for the JOINT-05. The trial is registered with the Japan Registry of Clinical Trials (jRCTs031180235) and the University Hospital Medical Information Network-Clinical Trials Registry (UMIN000015573).
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Acknowledgements
The authors express thanks to the chairman Dr. Itsuo Gorai and the members of the central ethics committee for the JOINT. JOINT-05 will be sponsored by the Public Health Research Foundation and Asahi Kasei Pharma Corp. Asahi Kasei Pharma Corp was not involved in the study design and writing of the manuscript. This study will also be supported in part by funding from the Project Promoting Clinical Trials for Development of New Drugs (19lk0201061t0004) from AMED to ST. The authors would like to thank everyone who will participate as clinical investigators in JOINT-05. We would like to thank FORTE Science Communications (www.forte-science.co.jp) for English language editing.
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TS, SM, and HH conceived of the hypothesis and design of this study. ST is the trial statistician and drafted the manuscript. All authors contributed to the final manuscript.
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ST has received lecture fees from Astra-Zeneca, Taiho, and Ono. He has received consultation fees from DeNA Life Science and CanBus. He has received outsourcing fees from Satt and Asahi Kasei Pharma. HH has received lecture and consultancy fees from Asahi Kasei Pharma Corp., Astellas Pharma Inc., MSD Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Pfizer Co., Ltd., Mitsubishi Tanabe Pharma Corp., Mochida Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Pfizer Inc., Taisho Toyama Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd. TS has received research grants from Astellas Pharma, Eisai, Daiichi-Sankyo, Chugai Pharmaceutical and Eli Lilly Japan as well as consulting and/or lecture fees from Asahi Kasei Pharma, MSD and Daiichi-Sankyo. SM has no conflicts of interest to disclose.
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Tanaka, S., Mori, S., Hagino, H. et al. Design of a randomized trial of teriparatide followed by alendronate: Japanese Osteoporosis Intervention Trial-05 (JOINT-05). J Bone Miner Metab 38, 412–417 (2020). https://doi.org/10.1007/s00774-019-01074-0
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DOI: https://doi.org/10.1007/s00774-019-01074-0