Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis

作者：Charles H. Chesnut, Arne Skag, Claus Christiansen, Robert R. Recker, J. A. Stakkestad, Arne Høiseth, Dieter Felsenberg, Hermann Huss, Jennifer Gilbride, Ralph C. Schimmer, Pierre D. Delmas, for the Oral Ibandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) · 发表于：Journal of Bone and Mineral Research · 年份：2004 · DOI：10.1359/jbmr.040325 · 被引用次数：1232 · 研究领域：Bone health and osteoporosis research、Bone health and treatments、Bone and Joint Diseases

UNLABELLED: Oral daily (2.5 mg) and intermittent ibandronate (between-dose interval of >2 months), delivering a similar cumulative exposure, were evaluated in 2946 osteoporotic women with prevalent vertebral fracture. Significant reduction in incident vertebral fracture risk by 62% and 50%, respectively, was shown after 3 years. This is the first study to prospectively show antifracture efficacy for the intermittent administration of a bisphosphonate. INTRODUCTION: Bisphosphonates are important therapeutics in postmenopausal osteoporosis. However, they are currently associated with stringent dosing instructions that may impair patient compliance and hence therapeutic efficacy. Less frequent, intermittent administration may help to overcome these deficiencies. This study assessed the efficacy and safety of oral ibandronate administered either daily or intermittently with a dose-free interval of >2 months. MATERIALS AND METHODS: This randomized, double-blind, placebo-controlled, parallel-group study enrolled 2946 postmenopausal women with a BMD T score < or = -2.0 at the lumbar spine in at least one vertebra (L1-L4) and one to four prevalent vertebral fractures (T4-L4). Patients received placebo or oral ibandronate administered either daily (2.5 mg) or intermittently (20 mg every other day for 12 doses every 3 months). RESULTS AND CONCLUSIONS: After 3 years, the rate of new vertebral fractures was significantly reduced in patients receiving oral daily (4.7%) and intermittent ib...