title: The efficacy and safety of weekly 35-mg risedronate dosing regimen for Chinese postmenopausal women with osteoporosis or osteopenia: 1-year data.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Jie-mei
authors.initials: JM
authors.lastname: Gu
authors.affiliation: Lab of Osteoporosis, Tianjin Hospital, Tianjin 300211, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: The Center of Research for Metabolic Bone Disease and The Affiliated Drum Tower Hospital of Medical School, Nanjing University, Nanjing 210008, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Lin
authors.affiliation: Department of Endocrinology, West China Hospital, Sichuan University, Chengdu 610041, China.
authors.forename: De-cai
authors.initials: DC
authors.lastname: Chen
authors.affiliation: Department of Orthopaedics, Beijing Shunyi Hospital, Beijing 101300, China.
authors.forename: Hai
authors.initials: H
authors.lastname: Tang
authors.affiliation: Department of Endocrinology, General Hospital of People's Liberation Army Chengdu Military Region, Chengdu 610083, China.
authors.forename: Xiao-lan
authors.initials: XL
authors.lastname: Jin
authors.affiliation: Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing 100730, China.
authors.forename: Wei-bo
authors.initials: WB
authors.lastname: Xia
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Yun-qiu
authors.initials: YQ
authors.lastname: Hu
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Wen-zhen
authors.initials: WZ
authors.lastname: Fu
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Jin-wei
authors.initials: JW
authors.lastname: He
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Hao
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Hua
authors.initials: H
authors.lastname: Yue
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Wei-wei
authors.initials: WW
authors.lastname: Hu
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Yu-juan
authors.initials: YJ
authors.lastname: Liu
authors.affiliation: Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Diseases, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 200233, China.
authors.forename: Zhen-lin
authors.initials: ZL
authors.lastname: Zhang
mesh_terms: D000368:Aged; D044466:Asian People; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001851:Bone Diseases, Metabolic / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D011446:Prospective Studies; D000068296:Risedronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid