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

In Jin Cho, Ho Yeon Chung, Sung Woon Kim, Jae Won Lee, Tae Won Lee, Hye Soon Kim, Sin Gon Kim, Han Seok Choi, Sung Hee Choi, Chan Soo Shin, Ki Won Oh, Yong Ki Min, Jung Min Koh, Yumie Rhee, Dong Won Byun, Yoon Sok Chung, Jeong Hyun Park, Dong Jin Chung, Minho Shong, Eun Gyoung HongChang Beom Lee, Ki Hyun Baek, Moo Il Kang

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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. Conclusion: 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.

Original languageEnglish
Pages (from-to)272-279
Number of pages8
JournalEndocrinology and Metabolism
Volume30
Issue number3
DOIs
StatePublished - 2015

Keywords

  • 25-hydroxyvitamin D
  • Bone markers
  • Cholecalciferol
  • Ibandronate

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