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KMID : 0356620150300030272
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Journal of Korean Society of Endocrinology
2015 Volume.30 No. 3 p.272 ~ p.279
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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
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:Cho In-Jin
:Chung Ho-Yeon/:Kim Sung-Woon/:Lee Jae-Won/:Lee Tae-Won/:Kim Hye-Soon/:Kim Sin-Gon/:Choi Han-Seok/:Choi Sung-Hee/:Shin Chan-Soo/:Oh Ki-Won/:Min Yong-Ki/:Koh Jung-Min/:Rhee Yu-Mie/:Byun Dong-Won/:Chung Yoon-Sok/:Park Jeong-Hyun/:Chung Dong-Jin/:Shong Min-Ho/:Hong Eun-Gyoung/:Lee Chang-Beom/:Baek Ki-Hyun/:Kang Moo-Il
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Abstract
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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.
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KEYWORD
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Ibandronate, Cholecalciferol, 25-hydroxyvitamin D, Bone markers
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