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

Affiliations
  • 1Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
  • 2Dreampharma Corp., Seoul, Korea.
  • 3Department of Endocrinology and Metabolism, Keimyung University School of Medicine, Daegu, Korea.
  • 4Department of Endocrinology and Metabolism, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
  • 5Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea.
  • 6Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
  • 7Division of Endocrinology and Metabolism, Department of Internal Medicine, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 8Divison of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 9Department of Internal Medicine, Endocrine Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 10Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.
  • 11Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
  • 12Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.
  • 13Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
  • 14Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.
  • 15Division of Endocrinology and Metabolism, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.
  • 16Department of Endocrinology and Metabolism, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
  • 17Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea. mikang@catholic.ac.kr

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
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