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Influence of symptomatic periodontal disease on changes in skeletal bone density during medication therapy for osteoporosis in postmenopausal women: the Japanese Osteoporosis Intervention Trial (JOINT)-04 and JOINT-05

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Abstract

Summary

Japanese postmenopausal women with symptomatic periodontal disease had a significantly smaller increase in the T-score for total hip bone density than those without periodontal disease during medication therapy for osteoporosis. Intervention to treat symptomatic periodontal disease before and/or during osteoporosis therapy could maintain the effect of osteoporosis medications.

Purpose

Women with periodontal disease may be more likely to develop osteoporosis. We evaluated whether the presence of symptomatic periodontal disease can influence changes in skeletal bone mineral density (BMD) during medication therapy for osteoporosis in Japanese postmenopausal women.

Methods

A total of 4,258 postmenopausal women participated in the Japanese Osteoporosis Intervention Trial protocol number 4 (JOINT-04 trial) and number 5 (JOINT-05 trial), which were multi-center, open-label, randomized controlled trials in Japan. Of these, 3,670 non-edentulous subjects participated in the study. Subjects who had self-reported symptoms of periodontal disease at baseline were defined as having periodontal disease. The study outcome was the difference in BMD changes during the study between subjects with and without periodontal disease. Mixed models for repeated measures after adjusting for covariates were used to investigate the difference in the BMD changes during the study between subjects with and without periodontal disease.

Results

Subjects with periodontal disease had significantly lower T-scores for total hip (p = 0.035) and metacarpal (p = 0.048) BMD than those without periodontal disease at baseline. During medication therapy for osteoporosis, subjects with periodontal disease had a significantly smaller increase in T-score for total hip BMD than those without periodontal disease (p = 0.021), although no significant differences were observed in the changes in T-scores for other skeletal BMD measurements between subjects with and without periodontal disease.

Conclusions

The presence of self-reported symptoms of periodontal disease may be associated with a decrease in the effect of osteoporosis medications in Japanese postmenopausal women.

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Acknowledgements

The authors would like to thank those who participated as clinical investigators in JOINT-04 and JOINT-05, the members of the central ethics committee, and the members of the data monitoring committee. The authors would like to express their sincere thanks to Dr. Masao Fukunaga, one of the independent evaluators of the X-rays. The authors would also like to express their sincere thanks to Mr. Teruhiko Miyazaki and Ms. Yuko Iwata for their secretarial help. We also thank Helen Jeays, BDSc AE, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.

Funding

This JOINT study was sponsored by the Public Health Research Foundation. This study was also supported in part by funding of the Project Promoting Clinical Trials for Development of New Drugs (19lk0201061t0004) from the AMED to S.T. and partially funded by JSPS KAKENHI grants provided to A.T. (grant number JP18K09758).

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Contributions

Conception and design: A. Taguchi, Y. Uemura, H. Ohta; analysis and interpretation of the data: A. Taguchi, Y. Uemura, S. Tanaka; drafting of the article: A. Taguchi, Y. Uemura, H. Ohta, S. Mori, H. Hagino; critical revision of the article for important intellectual content: M. Shiraki, T. Nakamura, S. Soen; final approval of the article: all the authors.

Corresponding author

Correspondence to Akira Taguchi.

Ethics declarations

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The protocol of JOINT-04/JOINT-05 was approved by the Central Ethical Committee for the Adequate Treatment of Osteoporosis (A-TOP) group.

Consent to participate

All patients provided written, informed consent.

Consent for publication

All patients provided written, informed consent.

Conflicts of interest

A. Taguchi has received lecture fees from Asahi Kasei Pharma Corp., Daiichi Sankyo Co. Ltd, Chugai Pharmaceutical Co. Ltd, and Teijin Pharma Ltd. He has received a consultation fee from Media Corp. Ltd. Y. Uemura has received outsourcing fees from Chugai Pharmaceutical Co. S. Tanaka has received lecture fees from Bayer Yakuhin, Amgen Astellas BioPharma K.K., and the Research Institute of Healthcare Data Science. He has received consultation fees and outsourcing fees from Daiichi Sankyo Co. Ltd, Boehringer Ingelheim, Satt, and the Public Health Research Foundation. He has received research grants from the Japan Agency for Medical Research and Development; the Japanese Ministry of Health Labor and Welfare; the Japanese Ministry of Education, Science, and Technology; and Novo Nordisk. He has engaged in a research project for the Japan Agency for Medical Research and Development. H. 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, Pfizer Japan Inc., Mitsubishi Tanabe Pharma Corp., Mochida Pharma Co. Ltd, Ono Pharmaceutical Co. Ltd, Pfizer Japan Inc., Taisho Pharmaceutical Co. Ltd, Teijin Pharma Ltd, and UCB Japan Co. Ltd. S. Soen has received consulting fees, speaking fees, and/or honoraria from Asahi Kasei Pharma, Astellas, Amgen, Daiichi-Sankyo, Eli Lilly Japan, and UCB Japan. M. Shiraki, H. Ohta, S. Mori, and T. Nakamura declare no competing interests.

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Taguchi, A., Uemura, Y., Tanaka, S. et al. Influence of symptomatic periodontal disease on changes in skeletal bone density during medication therapy for osteoporosis in postmenopausal women: the Japanese Osteoporosis Intervention Trial (JOINT)-04 and JOINT-05. Arch Osteoporos 17, 7 (2022). https://doi.org/10.1007/s11657-021-01054-w

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