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
N1 - Publisher Copyright:
© 2019, International Osteoporosis Foundation and National Osteoporosis Foundation.
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.
UR - http://www.scopus.com/inward/record.url?scp=85076346343&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.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
SN - 1862-3522
VL - 15
JO - Archives of Osteoporosis
JF - Archives of Osteoporosis
IS - 1
M1 - 3
ER -