Journal of Clinical Densitometry
Volume 11, Issue 2 , Pages 221-231 , April 2008

Vertebral Fracture Diagnosis in the Multinational BONE Study of Oral Ibandronate: Quality Management in Radiology

  • Gabriele Armbrecht

      Affiliations

    • Center of Muscle and Bone Research, Charite—Campus Benjamin Franklin, Berlin, Germany
    • Corresponding Author InformationAddress correspondence to: Gabriele Armbrecht, Center of Muscle and Bone Research, Charite—Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
  • ,
  • Tilo Blenk

      Affiliations

    • Center of Muscle and Bone Research, Charite—Campus Benjamin Franklin, Berlin, Germany
  • ,
  • Charles H. Chesnut III

      Affiliations

    • Osteoporosis Research Group, Department of Radiology, University of Washington, Seattle, WA, USA
  • ,
  • Jill C. Gardner

      Affiliations

    • Osteoporosis Research Group, Department of Radiology, University of Washington, Seattle, WA, USA
  • ,
  • Gabriele von Ingersleben

      Affiliations

    • Synarc, San Francisco, CA, USA
  • ,
  • Paul Mahoney

      Affiliations

    • F Hoffmann-La Roche Ltd., Basel, Switzerland
  • ,
  • Dieter Felsenberg

      Affiliations

    • Center of Muscle and Bone Research, Charite—Campus Benjamin Franklin, Berlin, Germany

Received 19 July 2007 ,Revised 5 October 2007 ,Accepted 5 October 2007.

References 

  1. Division of Metabolic and Endocrine Drug Products, Food and Drug Administration, Rockville, Maryland . Guidelines for preclinical and clinical evaluation of agents used in the prevention or treatment of postmenopausal osteoporosis. Available at: http://www.fda.gov/cder/guidance/osteo.pdf1994;Accessed September 16, 2004
  2. National Osteoporosis Foundation (NOF) Working Group on Vertebral Fractures Report . Assessing vertebral fractures. J Bone Miner Res. 1995;10:18–23
  3. Bauss F, Russell RGG. Ibandronate in osteoporosis: preclinical data and rationale for intermittent dosing. Osteoporos Int. 2004;15:423–433
  4. Chesnut CH, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004;19:1241–1249
  5. Black DM, Cummings SR, Karpf DB, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet. 1996;348:1535–1541
  6. Reginster J, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteoporos Int. 2000;11:83–91
  7. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA. 1999;282:1344–1352
  8. Recker RR, Stakkestad JA, Chesnut CH, et al. Insufficiently dosed i.v. ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis. Bone. 2004;34:890–899
  9. Yochum TR, Rowe LJ. 2nd ed.. Essentials of skeletal radiology. Vol. 1. Baltimore, MD: Williams & Wilkins; 1996;
  10. Wu C, van Kuijk C, Li J, et al. Comparison of Digitized Images with the original radiography for semiquantitative assessment of osteoporotic fractures. Osteoporos Int. 2000;11:25–30
  11. Tan TCF, Sartoris DJ, Resnick D. Differential diagnosis of osteoporotic vertebral fractures: pathology and radiology. In:  Genant HK,  Jergas M,  van Kuijk C editor. Vertebral Fracture in Osteoporosis. San Francisco, CA: Radiology Research and Education Foundation; 1995;p. 71–94
  12. In:  Daffner RH editors. Imaging of Vertebral Trauma. 2nd ed.. Philadelphia, PA: Lippincott-Raven; 1996;
  13. Resnick D, Goergen TG, Niwayama G. Physical injury. In:  Resnick D,  Niwayama G editor. 2nd ed.. Diagnosis of Bone and Joint Disorders. Vol. 5:Philadelphia, PA: Saunders Company; 1988;p. 2756–3008
  14. Garfin SR, Gertzbein S, Eismont F. Fractures of the lumbar spine: evaluation, classification, and treatment. In:  Wiesel SW,  Weinstein JN,  Herkowitz H,  Dvorak J,  Bell G editor. 2nd ed.. The Lumbar Spine. Vol. 2:Philadelphia, PA: Saunders Company; 1996;
  15. Dihlmann W. Gelenke - Wirbelverbindungen. 2nd ed.. Stuttgart, Germany: Georg Thieme; 1982;
  16. Taylor JAM, Resnick D. The aging spine: radiographic-pathologic correlation. In:  Genant HK,  Jergas M,  van Kuijk C editor. Vertebral Fracture in Osteoporosis. San Francisco, CA: Radiology Research and Education Foundation; 1995;p. 37–69
  17. Resnick D, Niwayama G. Intravertebral disk herniations: cartilaginous (Schmorl's) nodes. Radiology. 1978;126:57–65
  18. Resnick D. Osteochondroses. In:  Resnick D,  Niwayama G editor. 2nd ed.. Diagnosis of Bone and Joint Disorders. Vol. 5:Philadelphia, PA: Saunders Company; 1988;p. 3289–3334
  19. Ziegler R, Scheidt-Nave C, Leidig-Bruckner G. What is a vertebral fracture?. Bone. 1996;18(Suppl):169S–177S
  20. Jergas M, Felsenberg D. Assessment of vertebral fracture. In:  Genant HK,  Guglielmi G,  Jergas M editor. Bone Densitometry and Osteoporosis. Berlin: Springer Verlag; 1998;p. 227–267
  21. Felsenberg D. Differentialdiagnose osteoporotischer wirbelkörperfrakturen. In:  Ringe JD,  Meunier PJ editor. Senile Osteoporose. Stuttgart, Germany: Thieme Verlag; 1996;
  22. Wu CY, Li J, Jergas M, et al. Comparison of semiquantitative and quantitative techniques for the assessment of prevalent and incident vertebral fractures. Osteoporos Int. 1995;5:354–370
  23. Link TM, Guglielmi G, van Kuijk C, et al. Radiologic assessment of osteoporotic vertebral fractures: diagnostic and prognostic implications. Eur Radiol. 2005;15:1521–1532
  24. Donner A, Eliasziw M. A goodness of fit approach to inference procedures for the kappa statistic: confidence interval construction, significance testing and sample size estimation. Stat Med. 1992;11:1511–1519
  25. Fleiss JL. Statistical methods for rates and proportions. 2nd ed.. New York: John Wiley & Sons; 1981;p. 218

PII: S1094-6950(07)00212-0

doi: 10.1016/j.jocd.2007.10.002

Journal of Clinical Densitometry
Volume 11, Issue 2 , Pages 221-231 , April 2008