title: Risedronate therapy in patients with mild-to-moderate chronic kidney disease with osteoporosis: post-hoc analysis of data from the risedronate phase III clinical trials.
abstract: BACKGROUND
  The clinical effect of bisphosphonate treatment has not been clearly evaluated by kidney function in Japanese Chronic Kidney Disease (CKD) patients with osteoporosis. This study analyzed the data from three risedronate Japanese phase III trials. The clinical effect of risedronate therapy was evaluated in CKD patients with osteoporosis.
  
  
  METHODS
  The Japanese clinical trials involved 852 subjects who received risedronate (2.5 mg once daily or 17.5 mg once weekly) and whose estimated glomerular filtration rate (eGFR) were calculable and at ≥ 30 mL/min. The subjects were divided into subgroups according to the eGFR level: ≥ 90 mL/min/1.73 m2, ≥ 60 to < 90 mL/min/1.73 m2, ≥ 30 to < 60 mL/min/1.73 m2. Lumbar spine bone mineral density (BMD), bone turnover markers (BTMs) and adverse events were evaluated at 48 weeks.
  
  
  RESULTS
  Adverse event incidence was similar among three subgroups. There was also no exacerbation of impaired kidney function associated with risedronate administration in the subjects with eGFR above 30 mL/min/1.73 m2. Risedronate administration induced a significant increase in lumbar spine BMD and significant inhibition of BTMs in three subgroups.
  
  
  CONCLUSIONS
  The risedronate therapy showed similar clinical effects in CKD patients with osteoporosis compared to those without CKD.
authors.affiliation: Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, Japan. taki@wakayama-med.ac.jp.
authors.forename: Takashi
authors.identifier: http://orcid.org/0000-0002-6330-3784
authors.initials: T
authors.lastname: Shigematsu
authors.affiliation: Data Science Group, Clinical Development Department, EA Pharma Co., Ltd, Tokyo, Japan.
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Muraoka
authors.affiliation: Internal Medicine 1 Shimane University Faculty of Medicine, Shimane, Japan.
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
authors.affiliation: Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Nishizawa
mesh_terms: D000328:Adult; D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000453:epidemiology*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000188:drug therapy* / Q000453:epidemiology*; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology*; D000068296:Risedronic Acid / Q000627:therapeutic use*; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid
keywords: Biomarkers; Bone disease; Calcium; Chronic kidney disease (CKD); Osteoporosis; Treatment