Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis

the IDEAL Trial Investigators

Research output: Contribution to journalArticle

Abstract

Summary: The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups. Introduction: This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. Methods: This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment. Results: After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups. Conclusions: A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.

Original languageEnglish
Article number3
JournalArchives of Osteoporosis
Volume15
Issue number1
DOIs
StatePublished - 1 Dec 2020

Fingerprint

Cholecalciferol
Bone Density
Osteoporosis
Pelvic Bones
Spine
Serum
Parathyroid Hormone
Alkaline Phosphatase
Risedronate Sodium
Femur Neck
Photon Absorptiometry
Vitamin D
Hip
Safety
Therapeutics

Keywords

  • Bone mineral density
  • Cholecalciferol
  • Osteoporosis
  • Risedronic acid

Cite this

@article{70fca9181a094dc29cb76410b3ac8bcb,
title = "Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis",
abstract = "Summary: The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups. Introduction: This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. Methods: This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment. Results: After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups. Conclusions: A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.",
keywords = "Bone mineral density, Cholecalciferol, Osteoporosis, Risedronic acid",
author = "{the IDEAL Trial Investigators} and Park, {So Young} and Kang, {Moo Il} and Park, {Hyung Moo} and Yumie Rhee and Moon, {Seong Hwan} and Yoon, {Hyun Koo} and Koh, {Jung Min} and Chang, {Jae Suk} and Kim, {In Joo} and Won, {Ye Yeon} and Park, {Ye Soo} and Hoon Choi and Shin, {Chan Soo} and Yoon, {Taek Rim} and Yun, {Sung Cheol} and Chung, {Ho Yeon}",
year = "2020",
month = "12",
day = "1",
doi = "10.1007/s11657-019-0663-5",
language = "English",
volume = "15",
journal = "Archives of Osteoporosis",
issn = "1862-3522",
publisher = "Springer London",
number = "1",

}

Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis. / the IDEAL Trial Investigators.

In: Archives of Osteoporosis, Vol. 15, No. 1, 3, 01.12.2020.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis

AU - the IDEAL Trial Investigators

AU - Park, So Young

AU - Kang, Moo Il

AU - Park, Hyung Moo

AU - Rhee, Yumie

AU - Moon, Seong Hwan

AU - Yoon, Hyun Koo

AU - Koh, Jung Min

AU - Chang, Jae Suk

AU - Kim, In Joo

AU - Won, Ye Yeon

AU - Park, Ye Soo

AU - Choi, Hoon

AU - Shin, Chan Soo

AU - Yoon, Taek Rim

AU - Yun, Sung Cheol

AU - Chung, Ho Yeon

PY - 2020/12/1

Y1 - 2020/12/1

N2 - Summary: The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups. Introduction: This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. Methods: This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment. Results: After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups. Conclusions: A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.

AB - Summary: The efficacy of once-weekly risedronate with and without cholecalciferol in bone mineral density (BMD) in Korean patients with osteoporosis was compared. After 12 months, both spine and hip BMD increased significantly in both groups, but there was no significant difference between two groups. Introduction: This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. Methods: This was a prospective, 12-month, randomized, open-labeled, actively controlled trial involving 41 hospitals. A total of 841 subjects with osteoporosis were randomized to once-weekly risedronate (35 mg) and cholecalciferol (5600 IU) in a single pill (RSD+, n = 642) or once-weekly risedronate (35 mg) alone (RSD, n = 199). BMD was measured via dual-energy X-ray absorptiometry at the lumbar spine and hip, and the serum levels of 25-hydroxy vitamin D (25(OH) D), parathyroid hormone (PTH), and alkaline phosphatase (ALP) were assayed at baseline and after 12 months of treatment. Results: After 12 months, the lumbar spine, femoral neck, and total hip BMD increased significantly in both groups; there was no significant difference between two groups. Women in the RSD+ group exhibited significantly increased lumbar spine BMD, and subjects with previous fracture history in the RSD+ group had significantly increased total hip BMD compared with the RSD group. The serum 25(OH) D level increased significantly in the RSD+ group. The serum PTH level decreased in the RSD+ group but increased in the RSD group. The serum ALP level significantly decreased in both groups; there was no significant difference between two groups. Conclusions: A once-weekly pill containing risedronate and cholecalciferol had the equivalent antiresorptive efficacy on BMD compared with risedronate alone and improved 25(OH) D serum levels after 12 months of treatment without significant adverse events in Korean patients with osteoporosis.

KW - Bone mineral density

KW - Cholecalciferol

KW - Osteoporosis

KW - Risedronic acid

UR - http://www.scopus.com/inward/record.url?scp=85076346343&partnerID=8YFLogxK

U2 - 10.1007/s11657-019-0663-5

DO - 10.1007/s11657-019-0663-5

M3 - Article

C2 - 31820121

AN - SCOPUS:85076346343

VL - 15

JO - Archives of Osteoporosis

JF - Archives of Osteoporosis

SN - 1862-3522

IS - 1

M1 - 3

ER -