Abstract
Introduction
Older people aged over 75 are more prone to falls because physical functions become deteriorated along with aging, and also fracture risk is strongly correlated with age. We evaluated the effects of anti-osteoporosis agents, eldecalcitol (ELD) and alendronate (ALN) on physical functions by assessing dynamic and static postural balance in aged patients with osteoporosis.
Materials and methods
A randomized, open-label, controlled clinical trial has been conducted with 124 female patients aged 65 or over with osteoporosis. Patients were randomly assigned to receive either 0.75 μg of ELD once-a-day or 35 mg of ALN once-a-week for 24 weeks. The primary endpoint was the change in a postural balance index, adjusted composite equilibrium score (CES) of sensory organization test (SOT). The SOT equilibrium scores, leg muscle strength, and other physical functions were also evaluated.
Results
The Adjusted CES increased from baseline by 6.10% in the ELD group and 6.28% in the ALN group. There was no statistically significant difference between the two groups. The static postural balance at fixed platform were maintained in the ELD group, but declined in the ALN group. The dynamic postural balance at swaying platform and knee extension power increased from baseline in both groups.
Conclusions
These results suggest that ELD and ALN treatments may each be beneficial to improve postural balance control in older patients with osteoporosis via different mechanisms of action.
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Acknowledgement
The authors thank the members of the EFFECT Study Group: Tokuhisa Kanbara, Hideoki Matsuoka, Mitsuo Mitani, Akira Okamoto, Takashi Sato, and Chihiro Tanaka. We also thank Satoshi Kondo for the preparation of the manuscript. The study was supported by Chugai Pharmaceutical Co., Ltd. and Taisho Pharmaceutical Co., Ltd.
Funding
This work is funded by Chugai Pharmaceutical Co. Ltd., and Taisho Pharmaceutical Co. Ltd (JapicCTI-No. 122013).
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All the authors have equally contributed to the study. TS, AH, HSh, TH, YK, TI and HSa designed the study, contributed to the implementation, prepared the draft of the paper, and approved the final version.
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TS has received personal fees and non-financial support from Chugai Pharmaceutical Co. Ltd., during the conduct of the study. AH and HSh has nothing to disclose. TH reports personal fees from Daiichi Sankyo Co. Ltd., personal fees from Ono Pharmaceutical Co. Ltd., and personal fees from Pfizer Japan Inc., outside of the submitted work. YK and HSa are employees of Chugai Pharmaceutical Co. Ltd. TI is an employee of Taisho Pharmaceutical Co. Ltd.
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Suzuki, T., Harada, A., Shimada, H. et al. Assessment of eldecalcitol and alendronate effect on postural balance control in aged women with osteoporosis. J Bone Miner Metab 38, 859–867 (2020). https://doi.org/10.1007/s00774-020-01118-w
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DOI: https://doi.org/10.1007/s00774-020-01118-w