Endocrinol Metab.  2015 Sep;30(3):272-279. 10.3803/EnM.2015.30.3.272.

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

• Cho IJ
• Chung HY
• Kim SW
• Lee JW
• Lee TW
• Kim HS
• Kim SG
• Choi HS
• Choi SH
• Shin CS
• Oh KW
• Min YK
• Koh JM
• Rhee Y
• Byun DW
• Chung YS
• Park JH
• Chung DJ
• Shong M
• Hong EG
• Lee CB
• Baek KH
• Kang MI

• KMID: 2407077
• DOI: http://doi.org/10.3803/EnM.2015.30.3.272

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.

Keyword

Ibandronate; Cholecalciferol; 25-hydroxyvitamin D; Bone markers

MeSH Terms

Alkaline Phosphatase
Cholecalciferol*
Collagen Type I
Female
Humans
Osteoporosis*
Osteoporosis, Postmenopausal
Parathyroid Hormone
Prospective Studies
Vitamin D Deficiency
Alkaline Phosphatase
Cholecalciferol
Collagen Type I
Parathyroid Hormone

Figure

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  Fig. 1 Randomization scheme and patient disposition. IBN+, the group which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol; IBN, the group which received a once-monthly pill containing 150 mg ibandronate.

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  Fig. 2 Changes in mean serum 25(OH)D levels over the 16-week treatment period. IBN+, the group which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol; IBN, the group which received a once-monthly pill containing 150 mg ibandronate; 25(OH)D, 25-hydroxyvitamin D. aP<0.001.

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  Fig. 3 Changes in the distribution of patients according to 25-hydroxyvitamin D (25[OH]D) levels after the 16-week treatment period. IBN+, the group which received a once-monthly pill containing 150 mg ibandronate and 24,000 IU cholecalciferol; IBN, the group which received a once-monthly pill containing 150 mg ibandronate treatment period, grouped by baseline 25(OH)D levels.

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