Osteoporosis International

, Volume 13, Issue 6, pp 501–505

Risedronate Reduces the Risk of First Vertebral Fracture in Osteoporotic Women

Authors

  • R. P. Heaney
    • Creighton University, Omaha, Nebraska, USA
  • T. M. Zizic
    • Chesapeake Medical Research, Baltimore, Maryland, USA
  • I. Fogelman
    • Guy’s Hospital, London, UK
  • W. P. Olszynski
    • Midtown Medical Center, Saskatoon, Saskatchewan, Canada
  • P. Geusens
    • Limburg University Center, Diepenbeek, Belgium, and University Hospital, Maastricht, The Netherlands
  • C. Kasibhatla
    • Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, USA
  • N. Alsayed
    • Procter & Gamble Pharmaceuticals, Cincinnati, Ohio, USA
  • G. Isaia
    • University of Turin, Turin, Italy
  • M. W. Davie
    • Charles Salt Centre, Oswestry, Shropshire, UK;
  • C. H. Chesnut III
    • University of Washington, Seattle, Washington, USA
Original Article

DOI: 10.1007/s001980200061

Cite this article as:
Heaney, R., Zizic, T., Fogelman, I. et al. Osteoporos Int (2002) 13: 501. doi:10.1007/s001980200061

Abstract:

Risedronate treatment reduces the risk of vertebral fracture in women with existing vertebral fractures, but its efficacy in prevention of the first vertebral fracture in women with osteoporosis but without vertebral fractures has not been determined. We examined the risk of first vertebral fracture in postmenopausal women who were enrolled in four placebo-controlled clinical trials of risedronate and who had low lumbar spine bone mineral density (BMD) (mean T-score =–3.3) and no vertebral fractures at baseline. Subjects received risedronate 5 mg (n= 328) or placebo (n= 312) daily for up to 3 years; all subjects were given calcium (1000 mg daily), as well as vitamin D supplementation (up to 500 IU daily) if baseline serum 25-hydroxyvitamin D levels were low. The incidence of first vertebral fracture was 9.4% in the women treated with placebo and 2.6% in those treated with risedronate 5 mg (risk reduction of 75%, 95% confidence interval 37% to 90%; P= 0.002). The number of patients who would need to be treated to prevent one new vertebral fracture is 15. When subjects were stratified by age, similar significant reductions were observed in patients with a mean age of 64 years (risk reduction of 70%, 95% CI 8% to 90%; P= 0.030) and in those with a mean age of 76 years (risk reduction of 80%, 95% CI 7% to 96%; P= 0.024). Risedronate treatment therefore significantly reduces the risk of first vertebral fracture in postmenopausal women with osteoporosis, with a similar magnitude of effect early and late after the menopause.

Key words:Bone mineral density – Osteoporosis – Risedronate – Vertebral fracture

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2002