title: Vertebral fracture diagnosis in the multinational BONE study of oral ibandronate: quality management in radiology.
abstract: A multicenter trial has established the antifracture efficacy of oral daily (2.5mg) as well as intermittent (20mg every other day for 12 doses every 3 mo) ibandronate in women with postmenopausal osteoporosis. As diagnostic spinal radiographs for this trial were read at 2 centers, the study protocol included rigorous procedures for diagnosis of morphometric vertebral fractures. These included standardized qualitative and morphometric assessment methods for diagnosing vertebral osteoporotic fractures and consensus cross-validation procedures for maximizing fracture diagnostic accuracy and consistency between the 2 radiographic reading centers. Using these stringent measures, the between-center discrepancy in the diagnosis of prevalent fractures was only 8%. Furthermore, after cross-validation, discrepancy in the final diagnosis of incident fractures between centers was found for only 4 patients, resulting in a net gain of only 2 fractures in the trial. This meticulous methodology provided a highly effective means of identifying vertebral fractures and recruiting the trial population in which to assess the efficacy of ibandronate in postmenopausal osteoporosis.
authors.affiliation: Center of Muscle and Bone Research, Charite--Campus Benjamin Franklin, Berlin, Germany. gabi.armbrecht@charite.de
authors.forename: Gabriele
authors.initials: G
authors.lastname: Armbrecht
authors.forename: Tilo
authors.initials: T
authors.lastname: Blenk
authors.forename: Charles H
authors.initials: CH
authors.lastname: Chesnut
authors.forename: Jill C
authors.initials: JC
authors.lastname: Gardner
authors.forename: Gabriele
authors.initials: G
authors.lastname: von Ingersleben
authors.forename: Paul
authors.initials: P
authors.lastname: Mahoney
authors.forename: Dieter
authors.initials: D
authors.lastname: Felsenberg
mesh_terms: D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004164:Diphosphonates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077557:Ibandronic Acid; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications* / Q000517:prevention & control*; D011859:Radiography; D016103:Spinal Fractures / Q000000981:diagnostic imaging* / Q000209:etiology* / Q000517:prevention & control
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D000077557:Ibandronic Acid