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.
10.3803/EnM.2015.30.3.272
- Author:
In Jin CHO
1
;
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
Author Information
1. Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.
- Publication Type:Clinical Trial ; Randomized Controlled Trial ; Original Article
- Keywords:
Ibandronate;
Cholecalciferol;
25-hydroxyvitamin D;
Bone markers
- MeSH:
Alkaline Phosphatase;
Cholecalciferol*;
Collagen Type I;
Female;
Humans;
Osteoporosis*;
Osteoporosis, Postmenopausal;
Parathyroid Hormone;
Prospective Studies;
Vitamin D Deficiency
- From:Endocrinology and Metabolism
2015;30(3):272-279
- CountryRepublic of Korea
- Language:English
-
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.
