title: Efficacy of a Once-Monthly Pill Containing Ibandronate and Cholecalciferol on the Levels of 25-Hydroxyvitamin D and Bone Markers in Postmenopausal Women with Osteoporosis.
abstract: BACKGROUND
  The present study evaluated the efficacy of a combination of ibandronate and cholecalciferol on the restoration of the levels of 25-hydroxyvitamin D (25[OH]D) and various bone markers in postmenopausal women with osteoporosis.
  
  
  METHODS
  This was a randomized, double-blind, active-controlled, prospective 16-week clinical trial conducted in 20 different hospitals. A total of 201 postmenopausal women with osteoporosis were assigned randomly to one of two groups: the IBN group, which received a once-monthly pill containing 150 mg ibandronate (n=99), or the IBN+ group, which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol (n=102). Serum levels of 25(OH)D, parathyroid hormone (PTH), and various bone markers were assessed at baseline and at the end of a 16-week treatment period.
  
  
  RESULTS
  After 16 weeks of treatment, the mean serum levels of 25(OH)D significantly increased from 21.0 to 25.3 ng/mL in the IBN+ group but significantly decreased from 20.6 to 17.4 ng/mL in the IBN group. Additionally, both groups exhibited significant increases in mean serum levels of PTH but significant decreases in serum levels of bone-specific alkaline phosphatase and C-telopeptide of type 1 collagen (CTX) at 16 weeks; no significant differences were observed between the groups. However, in subjects with a vitamin D deficiency, IBN+ treatment resulted in a significant decrease in serum CTX levels compared with IBN treatment.
  
  
  CONCLUSIONS
  The present findings demonstrate that a once-monthly pill containing ibandronate and cholecalciferol may be useful for the amelioration of vitamin D deficiency in patients with postmenopausal osteoporosis. Moreover, this treatment combination effectively decreased serum levels of resorption markers, especially in subjects with a vitamin D deficiency, over the 16-week treatment period.
authors.affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
authors.forename: In Jin
authors.initials: IJ
authors.lastname: Cho
authors.affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
authors.forename: Ho Yeon
authors.initials: HY
authors.lastname: Chung
authors.affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
authors.forename: Sung Woon
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Dreampharma Corp., Seoul, Korea.
authors.forename: Jae Won
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Dreampharma Corp., Seoul, Korea.
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Lee
authors.affiliation: Department of Endocrinology and Metabolism, Keimyung University School of Medicine, Daegu, Korea.
authors.forename: Hye Soon
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Department of Endocrinology and Metabolism, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Sin Gon
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea.
authors.forename: Han Seok
authors.initials: HS
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Sung Hee
authors.initials: SH
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Chan Soo
authors.initials: CS
authors.lastname: Shin
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Ki Won
authors.initials: KW
authors.lastname: Oh
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yong Ki
authors.initials: YK
authors.lastname: Min
authors.affiliation: Divison of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jung Min
authors.initials: JM
authors.lastname: Koh
authors.affiliation: Department of Internal Medicine, Endocrine Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Yumie
authors.initials: Y
authors.lastname: Rhee
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
authors.forename: Dong Won
authors.initials: DW
authors.lastname: Byun
authors.affiliation: Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Yoon Sok
authors.initials: YS
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
authors.forename: Jeong Hyun
authors.initials: JH
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Dong Jin
authors.initials: DJ
authors.lastname: Chung
authors.affiliation: Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.
authors.forename: Minho
authors.initials: M
authors.lastname: Shong
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.
authors.forename: Eun Gyoung
authors.initials: EG
authors.lastname: Hong
authors.affiliation: Department of Endocrinology and Metabolism, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
authors.forename: Chang Beom
authors.initials: CB
authors.lastname: Lee
authors.affiliation: Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Ki Hyun
authors.initials: KH
authors.lastname: Baek
authors.affiliation: Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. mikang@catholic.ac.kr.
authors.forename: Moo Il
authors.initials: MI
authors.lastname: Kang
keywords: 25-hydroxyvitamin D; Bone markers; Cholecalciferol; Ibandronate