title: Efficacy on the risk of vertebral fracture with administration of once-weekly 17.5 mg risedronate in Japanese patients of established osteoporosis with prevalent vertebral fractures: a 156-week longitudinal observational study in daily practice.
abstract: Currently, the only available evidence for the efficacy of once-weekly 17.5 mg risedronate in preventing vertebral fractures was obtained in a 48-week study in Japan. We performed a 156-week prospective, longitudinal, observational study to determine the efficacy of the 17.5 mg risedronate in preventing vertebral fractures. We included Japanese patients with established osteoporosis who were older than 50 years and had radiographically confirmed vertebral fractures. The primary endpoint was the incidence of vertebral fractures every 24 weeks, with the final interval spanning 36 weeks. We also calculated the change in bone mineral density of the lumbar spine (L2-4BMD) and urinary N-telopeptide of type I collagen (u-NTX), and assessed the incidence of adverse drug reactions and the drug adherence rate. Data from 241 patients were available for analysis of vertebral fracture prevention. The incidence rate of vertebral fractures decreased in a time-dependent manner (P = 0.0006; Poisson regression analysis). The risk ratio (fracture incidence per 100 person-years in the final 36 weeks versus that in the first 24 weeks) was 0.21 (95 % confidence interval 0.08-0.55). Compared to baseline values, L2-4BMD increased by 6.41 % at 156 weeks, while u-NTX decreased by 36 % at 24 weeks and was maintained thereafter (P < 0.0001). The incidence rate of adverse drug reactions was 9.18 %. Drug adherence rates assessed every 4 weeks were over 90 %. Our results indicate that 156 weeks of treatment with once-weekly 17.5 mg risedronate effectively reduced the risk of vertebral fracture in Japanese patients with established osteoporosis older than 50 years.
authors: Department of Orthopaedic Surgery and Rheumatology, Nara Hospital, Kindai University Faculty of Medicine, 1248-1 Otodacho, Ikoma, Nara, 630-0293, Japan.
authors: Satoshi
authors: S
authors: Soen
authors: Post-marketing Medical Research Department, Ajinomoto Pharmaceuticals Co., Ltd., 1-1 Irifune 2-Chome, Chuo-ku, Tokyo, 104-0042, Japan. takashi_umemura@eapharma.co.jp.
authors: Takashi
authors: T
authors: Umemura
authors: Post-marketing Medical Research Department, Ajinomoto Pharmaceuticals Co., Ltd., 1-1 Irifune 2-Chome, Chuo-ku, Tokyo, 104-0042, Japan.
authors: Tsuyoshi
authors: T
authors: Ando
authors: Post-marketing Medical Research Department, Ajinomoto Pharmaceuticals Co., Ltd., 1-1 Irifune 2-Chome, Chuo-ku, Tokyo, 104-0042, Japan.
authors: Toshiaki
authors: T
authors: Kamisaki
authors: Post-marketing Medical Research Department, Ajinomoto Pharmaceuticals Co., Ltd., 1-1 Irifune 2-Chome, Chuo-ku, Tokyo, 104-0042, Japan.
authors: Masahiko
authors: M
authors: Nishikawa
authors: Data Science Group, Clinical Development Department, Ajinomoto Pharmaceuticals Co., Ltd., 1-1 Irifune 2-Chome, Chuo-ku, Tokyo, 104-0042, Japan.
authors: Ryoichi
authors: R
authors: Muraoka
authors: Post-marketing Surveillance Group, Pharmacovigilance Department, Japan Development Center, Takeda Pharmaceutical Co., Ltd., 1-1 Doshomachi 4-Chome, Chuo-ku, Osaka, 540-8645, Japan.
authors: Yoshinori
authors: Y
authors: Ikeda
authors: Post-marketing Surveillance Group, Pharmacovigilance Department, Japan Development Center, Takeda Pharmaceutical Co., Ltd., 1-1 Doshomachi 4-Chome, Chuo-ku, Osaka, 540-8645, Japan.
authors: Kyoko
authors: K
authors: Takeda
authors: Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs, Eisai Co., Ltd., 6-10 Koishikawa 4-Chome, Bunkyo-ku, Tokyo, 112-8088, Japan.
authors: Mitsuharu
authors: M
authors: Osawa
authors: National Center for Global Health and Medicine, 21-1 Toyama 1-Chome, Shinjuku-ku, Tokyo, 162-8655, Japan.
authors: Toshitaka
authors: T
authors: Nakamura
mesh_terms: D000368:Aged; D044466:Asian People; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D024042:Collagen Type I / Q000652:urine; D004334:Drug Administration Schedule; D005260:Female; D006620:Hip Fractures / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D007564:Japan; D008137:Longitudinal Studies; D008159:Lumbar Vertebrae / Q000187:drug effects; D008297:Male; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D010349:Patient Compliance; D010455:Peptides / Q000652:urine; D015995:Prevalence; D011446:Prospective Studies; D000068296:Risedronic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D016103:Spinal Fractures / Q000150:complications / Q000453:epidemiology* / Q000503:physiopathology / Q000652:urine
chemical_list: D050071:Bone Density Conservation Agents; D024042:Collagen Type I; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D000068296:Risedronic Acid
keywords: Established osteoporosis; Lumbar bone mineral density; Observational study; Once-weekly risedronate; Risk of vertebral fracture