Thus, vitamin D insufficiency or deficiency may not have been a m

Thus, vitamin D insufficiency or deficiency may not have been a major factor for the lack of effects of isoflavones. (3) We did not collect data on hot flashes that could have served as a reflection of the biological effect and the appropriateness of the dosage of the isoflavones used in this study, in addition to this website the serum levels of isoflavones. (4) We used three different models of instruments from three different manufacturers to measure BMD. The variations among the three instruments may have masked the effects of soy isoflavones. However, we performed BMD measurements according to the International Society of Clinical

Densitometry guidelines. The instruments had daily quality checks and were operated by the same technologists throughout the period of study. The results within each center were analyzed separately and did not show any trend of effects. (5) A lack of total proximal femur BMD data from one center may have reduced the power to estimate the effect of soy isoflavones. However, it is difficult to perceive how isoflavone treatment

could improve proximal femur BMD while providing no C646 benefit in preventing bone loss at the lumbar spine. (6) Our sample size was not sufficient to analyze the effects of soy isoflavone on buy URMC-099 fracture rates. The fracture incidence in our study appeared higher than the results reported by a prospective study in Shanghai, China [41]. It should be noted that our study included only osteopenic or osteoporotic women, whereas the study in Shanghai included a cohort from the general population. However, in view of 64% increase in bone fracture rate in the isoflavone arm compared with that of the

placebo arm, more cautious monitoring in this regard is warranted in the future studies. Conclusions The current double-blind, randomized, placebo-controlled study of soy-extracted isoflavones on bone health failed to detect either an antiresorptive or a bone-sparing effect, despite possessing the strengths of larger dose, long observation period, and high compliance rate. Acknowledgments Thymidine kinase We would like to thank the three local hospitals, National Taiwan University Hospital, Changhua Christian Hospital, and Cheng Kung University Hospital, for their support in clinical observation and laboratory tests; we also appreciate the assistance of Taiwan Biotech Co. Ltd, Taiwan for its generous provision of isoflavones. Additionally, the authors are grateful for all the subjects who participated in this study. Grand support This study was supported by GE-PP02 grant “A Taiwan Isoflavone Multicenter Study (TIMS)” from the National Health Research Institutes, Zhunan, Taiwan. The funding source supervised the design, conduct, management and analysis, but was not involved in the interpretation of the study result. Conflicts of interest None.

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