title: Early changes in 25-hydroxyvitamin D levels and bone markers after monthly risedronate with cholecalciferol in Korean patients with osteoporosis.
abstract: OBJECTIVE
  This study investigated the efficacy and safety of monthly risedronate, with and without cholecalciferol, on 25-hydroxyvitamin D (25[OH]D) levels and bone markers in Korean patients with osteoporosis.
  
  
  METHODS
  A randomized, double-blinded, prospective, 16-week clinical trial was conducted in ten hospitals. A total of 150 subjects with osteoporosis were randomized to one of the two treatment groups: RSDM+ (monthly risedronate 150 mg and cholecalciferol 30,000 IU combined in a single pill, n = 74) or RSDM (monthly risedronate 150 mg alone, n = 76). We measured serum levels of 25-hydroxyvitamin D (25[OH]D), parathyroid hormone (PTH), and bone markers, as well as performing muscle-function tests at baseline and after 16 weeks of treatment.
  
  
  RESULTS
  After 16 weeks, serum 25(OH)D levels significantly increased from 17.8 to 26.8 ng/mL in the RSDM+ group, but did not change in the RSDM group. The RSDM+ group exhibited significantly decreased serum PTH from 46 to 36.7 pg/mL, while the RSDM group showed a tendency for PTH to increase from 38 to 40.6 pg/mL. In both groups, serum bone-specific alkaline phosphatase and C-terminal telopeptide rapidly declined, with significance at 16 weeks; there were no significant differences between the groups.
  
  
  CONCLUSIONS
  A once-monthly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D levels over the 16-week treatment period without significant adverse events in Korean patients with osteoporosis.
authors.affiliation: Department of Internal Medicine, Kyung Hee University, South Korea.
authors.forename: Ho Yeon
authors.initials: HY
authors.lastname: Chung
authors.forename: Jawon
authors.initials: J
authors.lastname: Koo
authors.forename: Su Kyoung
authors.initials: SK
authors.lastname: Kwon
authors.forename: Moo-Il
authors.initials: MI
authors.lastname: Kang
authors.forename: Seong-Hwan
authors.initials: SH
authors.lastname: Moon
authors.forename: Jin-Young
authors.initials: JY
authors.lastname: Park
authors.forename: Chan Soo
authors.initials: CS
authors.lastname: Shin
authors.forename: Byung-Koo
authors.initials: BK
authors.lastname: Yoon
authors.forename: Hyun-Koo
authors.initials: HK
authors.lastname: Yoon
authors.forename: Jae-Suk
authors.initials: JS
authors.lastname: Chang
authors.forename: Yoon-Sok
authors.initials: YS
authors.lastname: Chung
authors.forename: Hyoung-Moo
authors.initials: HM
authors.lastname: Park
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002762:Cholecalciferol / Q000008:administration & dosage*; D024042:Collagen Type I / Q000097:blood; D004311:Double-Blind Method; D004338:Drug Combinations; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy*; D010455:Peptides / Q000097:blood; D011446:Prospective Studies; D056910:Republic of Korea; D000068296:Risedronic Acid; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D004338:Drug Combinations; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D014807:Vitamin D; D002762:Cholecalciferol; C104450:25-hydroxyvitamin D; D000469:Alkaline Phosphatase; D000068296:Risedronic Acid; D012968:Etidronic Acid
keywords: 25(OH)D; bisphosphonate; bone markers; cholecalciferol