A Placebo-Controlled, Single-Blind Study to Determine the Appropriate Alendronate Dosage in Postmenopausal Japanese Patients with Osteoporosis

Endocrine Journal

HIDEAKI KISHIMOTO⁵  KAZUHIRO KUSHIDA²  HAJIME ORIMO^1,10  MASATAKA SHIRAKI³  MASAO FUKUNAGA⁴  AKIO TOMITA⁸  HIROSHI MINAGUCHI⁶  KIYOSHI KANEDA¹  MITSUYOSHI NAKASHIMA⁷  TETSUO INOUE²  YUKIHIRO NAGATA⁹ 

[1] epartment of Orthopedic Surgery, Hokkaido University School of Medicine;Department of Orthopedic Surgery, Hamamatsu University School of Medicine;Department of Laboratory Medicine, Tokyo Metropolitan Geriatric Hospital;Department of Radioisotope, Kawasaki Medical School;Department of Orthopedic Surgery, Faculty of Medicine, Tottori University;Department of Obstetrics and Gynecology, Yokohama City University School of Medicine;Department of Pharmacology, Hamamatsu University School of Medicine;Department of Clinical Laboratories, Aichi Medical University;Department of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University;Department of Geriatrics, Faculty of Medicine, The University of Tokyo

关键词: Osteoporosis;    Bone mineral density;    Bone metabolic markers;    Alendronate;    Asian;   

DOI  :  10.1507/endocrj.45.191

学科分类：内分泌与代谢学

来源: Japan Endocrine Society

【 摘 要 】

References(23)Cited-By(26)Alendronate (4-amino-1-hydroxybutylidene-1, 1-bisphosphonate) is a potent inhibitor of bone resorption. The efficacy and safety of 36 weeks of treatment with alendronate were evaluated in Japanese women with osteoporosis, osteoporotic osteopenia or artificial menopause. The bone mineral density (BMD) of the lumbar vertebrae, markers of bone and calcium metabolism and clinical symptoms were monitored. A total of 113 randomly selected patients with osteoporosis or osteopenia were enrolled in the study, of whom 12 were excluded from the analyses because of lack of data. As a result, 101 patients were evaluated for the safety of the drug. Since eight patients were excluded from the efficacy analysis, 93 were evaluated. The incidence of adverse effects in the placebo (P), alendronate 2.5 mg/day (L) and alendronate 10mg/day (H) groups increased with increasing dose of alendronate, being 6.1, 14.3 and 18.2%, respectively. The most common adverse effects were gastrointestinal symptoms, none of which was serious. Lumbar BMD increased after 36 weeks of drug administration to 5.21%, 5.64% and -0.90% in the L, H and P groups, respectively (P<0.001, L vs. P and H vs. P). Serum alkaline phosphatase activity, serum osteocalcin and urinary deoxypyridinoline excretion were significantly decreased in a dose-related manner. Serum calcium and phosphorus were also significantly decreased after alendronate administration. Serum intact PTH was transiently increased. The present results indicate that alendronate effectively decreases bone turnover in a dose-related manner and increases lumbar BMD at a dosage of 2.5mg/day, the lowest dose used in this study, in Japanese patients with osteoporosis.

【 授权许可】

Unknown