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 HongChang Beom Lee, Ki Hyun Baek, Moo Il Kang

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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.

Original languageEnglish
Pages (from-to)272-279
Number of pages8
JournalEndocrinology and Metabolism
Volume30
Issue number3
DOIs
Publication statusPublished - 2015 Jan 1

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Cholecalciferol
Osteoporosis
Bone and Bones
Vitamin D Deficiency
Serum
Parathyroid Hormone
Therapeutics
Postmenopausal Osteoporosis
Collagen Type I
Alkaline Phosphatase
25-hydroxyvitamin D
ibandronic acid
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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, Yumie ; Byun, Dong Won ; Chung, Yoon Sok ; Park, Jeong Hyun ; Chung, Dong Jin ; Shong, Minho ; Hong, Eun Gyoung ; Lee, Chang Beom ; Baek, Ki Hyun ; Kang, Moo Il. / 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: Endocrinology and Metabolism. 2015 ; Vol. 30, No. 3. pp. 272-279.
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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.",
author = "Cho, {In Jin} and Chung, {Ho Yeon} and Kim, {Sung Woon} and Lee, {Jae Won} and Lee, {Tae Won} and Kim, {Hye Soon} and Kim, {Sin Gon} and Choi, {Han Seok} and Choi, {Sung Hee} and Shin, {Chan Soo} and Oh, {Ki Won} and Min, {Yong Ki} and Koh, {Jung Min} and Yumie Rhee and Byun, {Dong Won} and Chung, {Yoon Sok} and Park, {Jeong Hyun} and Chung, {Dong Jin} and Minho Shong and Hong, {Eun Gyoung} and Lee, {Chang Beom} and Baek, {Ki Hyun} and Kang, {Moo Il}",
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issn = "2093-596X",
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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 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', Endocrinology and Metabolism, vol. 30, no. 3, pp. 272-279. https://doi.org/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, 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, Yumie; Byun, Dong Won; Chung, Yoon Sok; Park, Jeong Hyun; Chung, Dong Jin; Shong, Minho; Hong, Eun Gyoung; Lee, Chang Beom; Baek, Ki Hyun; Kang, Moo Il.

In: Endocrinology and Metabolism, Vol. 30, No. 3, 01.01.2015, p. 272-279.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Cho, In Jin

AU - Chung, Ho Yeon

AU - Kim, Sung Woon

AU - Lee, Jae Won

AU - Lee, Tae Won

AU - Kim, Hye Soon

AU - Kim, Sin Gon

AU - Choi, Han Seok

AU - Choi, Sung Hee

AU - Shin, Chan Soo

AU - Oh, Ki Won

AU - Min, Yong Ki

AU - Koh, Jung Min

AU - Rhee, Yumie

AU - Byun, Dong Won

AU - Chung, Yoon Sok

AU - Park, Jeong Hyun

AU - Chung, Dong Jin

AU - Shong, Minho

AU - Hong, Eun Gyoung

AU - Lee, Chang Beom

AU - Baek, Ki Hyun

AU - Kang, Moo Il

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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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