@article{APS9356,
author = {Jie-mei Gu and Li Wang and Hua Lin and De-cai Chen and Hai Tang and Xiao-lan Jin and Wei-bo Xia and Yun-qiu Hu and Wen-zhen Fu and Jin-wei He and Hao Zhang and Chun Wang and Hua Yue and Wei-wei Hu and Yu-juan Liu and Zhen-lin Zhang},
title = {The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data},
journal = {Acta Pharmacologica Sinica},
volume = {36},
number = {7},
year = {2017},
keywords = {},
abstract = {Aim: Oral risedronate is effective in the treatment of postmenopausal osteoporosis when administered daily, weekly, or monthly. In this 1-year, randomized, double-blind, multicenter study we compared the weekly 35-mg and daily 5-mg risedronate dosing regimens in the treatment of Chinese postmenopausal women with osteoporosis or osteopenia.
Methods: Postmenopausal women with primary osteoporosis or osteopenia were randomly assigned to the weekly group or daily group (n=145 for each) that received oral risedronate 35 mg once a week or 5 mg daily, respectively, for 1 year. The subjects' bone mineral densities (BMDs), bone turnover markers (P1NP and β-CTX), new vertebral fractures, and adverse events were assessed at baseline and during the treatments.
Results: All subjects in the weekly group and 144 subjects in the daily group completed the study. The primary efficacy endpoint after 1 year, ie the mean percent changes in the lumbar spine BMD (95% CI) were 4.87% (3.92% to 5.81%) for the weekly group and 4.35% (3.31% to 5.39%) for the daily group. The incidences of clinical adverse events were 48.3% in the weekly group and 54.2% in the daily group.
Conclusion: The weekly 35-mg and daily 5-mg risedronate dosing regimens during 1 year of follow-up show similar efficacy in improving BMDs and biochemical markers of bone turnover in Chinese postmenopausal women with osteoporosis or osteopenia. Moreover, the two dosing regimens exhibit similar safety and tolerability.},
issn = {1745-7254}, url = {http://www.chinaphar.com/article/view/9356}
}