Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis

Ho Yeon Chung, Sang Ouk Chin, Moo Il Kang, Jung Min Koh, seonghwan moon, Byung Koo Yoon, Hyun Koo Yoon, Yoon Sok Chung, Hyoung Moo Park

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. Results After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. Conclusion In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.

Original languageEnglish
Pages (from-to)699-704
Number of pages6
JournalClinical Endocrinology
Volume74
Issue number6
DOIs
Publication statusPublished - 2011 Jun 1

Fingerprint

Bone Remodeling
Cholecalciferol
Osteoporosis
Parathyroid Hormone
Serum
Bone and Bones
Therapeutics
Alkaline Phosphatase
Lower Extremity
25-hydroxyvitamin D
Risedronate Sodium
Clinical Trials
Safety
Muscles
Incidence

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Chung, Ho Yeon ; Chin, Sang Ouk ; Kang, Moo Il ; Koh, Jung Min ; moon, seonghwan ; Yoon, Byung Koo ; Yoon, Hyun Koo ; Chung, Yoon Sok ; Park, Hyoung Moo. / Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis. In: Clinical Endocrinology. 2011 ; Vol. 74, No. 6. pp. 699-704.
@article{87ccbb4bb2954836abaade8526ca84d0,
title = "Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis",
abstract = "Background We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. Results After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. Conclusion In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.",
author = "Chung, {Ho Yeon} and Chin, {Sang Ouk} and Kang, {Moo Il} and Koh, {Jung Min} and seonghwan moon and Yoon, {Byung Koo} and Yoon, {Hyun Koo} and Chung, {Yoon Sok} and Park, {Hyoung Moo}",
year = "2011",
month = "6",
day = "1",
doi = "10.1111/j.1365-2265.2011.04041.x",
language = "English",
volume = "74",
pages = "699--704",
journal = "Clinical Endocrinology",
issn = "0300-0664",
publisher = "Wiley-Blackwell",
number = "6",

}

Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis. / Chung, Ho Yeon; Chin, Sang Ouk; Kang, Moo Il; Koh, Jung Min; moon, seonghwan; Yoon, Byung Koo; Yoon, Hyun Koo; Chung, Yoon Sok; Park, Hyoung Moo.

In: Clinical Endocrinology, Vol. 74, No. 6, 01.06.2011, p. 699-704.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of risedronate with cholecalciferol on 25-hydroxyvitamin D level and bone turnover in Korean patients with osteoporosis

AU - Chung, Ho Yeon

AU - Chin, Sang Ouk

AU - Kang, Moo Il

AU - Koh, Jung Min

AU - moon, seonghwan

AU - Yoon, Byung Koo

AU - Yoon, Hyun Koo

AU - Chung, Yoon Sok

AU - Park, Hyoung Moo

PY - 2011/6/1

Y1 - 2011/6/1

N2 - Background We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. Results After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. Conclusion In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.

AB - Background We performed a randomized, double-blind, prospective, 16-week clinical trial to evaluate the efficacy and safety of risedronate with and without cholecalciferol on 25-hydroxyvitamin D [25(OH)D] levels and bone markers in Korean patients with osteoporosis. Methods We randomly assigned 164 adults with osteoporosis to one of two treatment groups: weekly risedronate 35 mg and cholecalciferol 5600 IU combined in a single pill (RSD+) or weekly risedronate 35 mg alone (RSD). We measured serum levels of 25(OH)D, parathyroid hormone (PTH), and bone markers and performed muscle function tests, at baseline and after 16 weeks of treatment. Results After 16 weeks of treatment, mean serum 25(OH)D increased significantly from 39·8 to 70·8 nmol/l in the RSD+ group and declined significantly from 40·5 to 35 nmol/l in the RSD group. Although both treatment groups had significant increases in serum PTH over baseline during the study, the RSD group had a significantly larger increase than the RSD+ group (13·6 vs 4·8 ng/l; P = 0·0005). In both groups, serum bone-specific alkaline phosphatase (BSAP) and C-terminal telopeptide (CTX) declined rapidly; there were no significant differences between groups. There was also no significant difference between groups in lower-extremity function tests. The overall incidence of clinical adverse events was not significantly different between groups. Conclusion In patients with osteoporosis, a once-weekly pill of risedronate and cholecalciferol provided equivalent antiresorptive efficacy to risedronate alone in terms of bone turnover and improved 25(OH)D level over a 16-week treatment period without significant adverse events.

UR - http://www.scopus.com/inward/record.url?scp=79955841644&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79955841644&partnerID=8YFLogxK

U2 - 10.1111/j.1365-2265.2011.04041.x

DO - 10.1111/j.1365-2265.2011.04041.x

M3 - Article

VL - 74

SP - 699

EP - 704

JO - Clinical Endocrinology

JF - Clinical Endocrinology

SN - 0300-0664

IS - 6

ER -