1. Efficacy of risedronate with cholecalciferol on bone mineral density in Korean patients with osteoporosis
- Author
-
Moo-Il Kang, So Young Park, Hyung Moo Park, In Joo Kim, Hoon Choi, Ye Soo Park, Chan Soo Shin, Sung-Cheol Yun, Ideal Trial Investigators, Taek Rim Yoon, Ye-Yeon Won, Hyun Koo Yoon, Jae Suk Chang, Ho-Yeon Chung, Yumie Rhee, Jung-Min Koh, and Seong Hwan Moon
- Subjects
musculoskeletal diseases ,0301 basic medicine ,medicine.medical_specialty ,Osteoporosis ,Urology ,Parathyroid hormone ,030209 endocrinology & metabolism ,Drug Administration Schedule ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Absorptiometry, Photon ,Randomized controlled trial ,law ,Bone Density ,Republic of Korea ,medicine ,Vitamin D and neurology ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Vitamin D ,Pelvic Bones ,Femoral neck ,Aged ,Cholecalciferol ,Bone mineral ,Lumbar Vertebrae ,Bone Density Conservation Agents ,business.industry ,Femur Neck ,Middle Aged ,medicine.disease ,Alkaline Phosphatase ,medicine.anatomical_structure ,Treatment Outcome ,chemistry ,Parathyroid Hormone ,Risedronic acid ,Drug Therapy, Combination ,Female ,030101 anatomy & morphology ,business ,Risedronic Acid ,medicine.drug - Abstract
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. This study investigated the efficacy and safety of once-weekly risedronate with and without cholecalciferol in BMD in Korean patients with osteoporosis. 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. 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. 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.
- Published
- 2019