Endocrinology and Metabolism (Sep 2015)

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 Hong,
  • Chang Beom Lee,
  • Ki Hyun Baek,
  • Moo-Il Kang

DOI
https://doi.org/10.3803/EnM.2015.30.3.272
Journal volume & issue
Vol. 30, no. 3
pp. 272 – 279

Abstract

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BackgroundThe 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.MethodsThis 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.ResultsAfter 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.ConclusionThe 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.

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