TY  - JOUR
AU  - Gu Jie-mei
AU  - Wang Li
AU  - Lin Hua
AU  - Chen De-cai
AU  - Tang Hai
AU  - Jin Xiao-lan
AU  - Xia Wei-bo
AU  - Hu Yun-qiu
AU  - Fu Wen-zhen
AU  - He Jin-wei
AU  - Zhang Hao
AU  - Wang Chun
AU  - Yue Hua
AU  - Hu Wei-wei
AU  - Liu Yu-juan
AU  - Zhang Zhen-lin
PY  - 2017
TI  - The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data
JF  - Acta Pharmacologica Sinica; Vol 36, No 7 (July 2015): Acta Pharmacologica Sinica
Y2  - 2017
KW  - 
N2  -  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.
UR  - http://www.chinaphar.com/article/view/9356