Journal of Bone and Mineral Metabolism

, Volume 22, Issue 5, pp 462–468

Alendronate reduced vertebral fracture risk in postmenopausal Japanese women with osteoporosis: a 3-year follow-up study

  • Kazuhiro Kushida
  • Masataka Shiraki
  • Toshitaka Nakamura
  • Hideaki Kishimoto
  • Hirotoshi Morii
  • Kichizo Yamamoto
  • Kiyoshi Kaneda
  • Masao Fukunaga
  • Tetsuro Inoue
  • Mitsuyoshi Nakashima
  • Hajime Orimo
Article

DOI: 10.1007/s00774-004-0508-0

Cite this article as:
Kushida, K., Shiraki, M., Nakamura, T. et al. J Bone Miner Metab (2004) 22: 462. doi:10.1007/s00774-004-0508-0

Abstract

The risk-reducing effect of alendronate on vertebral fractures has been consistently reported. In a 2-year, randomized, double-blind, active drug-controlled (1 µg alfacalcidol) double-dummy study, we also reported that alendronate (5.0 mg) had a fracture-reducing effect in Japanese patients with preexisting vertebral fractures. The present report describes the risk-reducing effect of alendronate (5.0 mg) for 3 years in postmenopausal osteoporotic patients. The 3-year treatment period consisted of the original 2-year double-blind study followed by a 1-year extension. A total of 170 postmenopausal female patients were involved in the third year; 90 received alendronate and 80 received alfacalcidol. Both efficacy and safety were analyzed in these 170 patients. Vertebral fracture was determined by quantitative morphometry, and vertebral bone mineral density (BMD) was measured by the DXA method (dual-energy X-ray absorptiometry). The primary efficacy endpoint was the incidence of vertebral fracture, excluding fracture cases that occurred in the first 6 months after treatment initiation. The cumulative incidence of vertebral fracture at 3 years was 7.8% (7/90) in the alendronate group and 18.8% (15/80) in the alfacalcidol group, indicating a significantly reduced risk of fractures in the alendronate group (relative risk = 0.41, 95% CI = 0.18–0.97). Lumbar spine BMD increased by 9.2% in the alendronate group (n = 26) and by 1.4% in the alfacalcidol group (n = 22) at 3 years. The safety profile of alendronate during 3 years of treatment was similar to that of alfacalcidol. The present study thus demonstrated that treatment with alendronate 5.0 mg for 3 years increased vertebral BMD and reduced the risk of vertebral fractures in Japanese, postmenopausal women with osteoporosis.

Key words

alendronateosteoporosisvertebral fracturealfacalcidol

Copyright information

© Springer-Verlag Tokyo 2004

Authors and Affiliations

  • Kazuhiro Kushida
    • 1
  • Masataka Shiraki
    • 2
  • Toshitaka Nakamura
    • 3
  • Hideaki Kishimoto
    • 4
  • Hirotoshi Morii
    • 5
  • Kichizo Yamamoto
    • 6
  • Kiyoshi Kaneda
    • 7
  • Masao Fukunaga
    • 8
  • Tetsuro Inoue
    • 9
  • Mitsuyoshi Nakashima
    • 10
  • Hajime Orimo
    • 11
  1. 1.Department of Orthopedic SurgeryHamamatsu University School of MedicineHamamatsuJapan
  2. 2.Research Institute and Practice for Involutional DiseasesNaganoJapan
  3. 3.University of Occupational and Environmental HealthFukuokaJapan
  4. 4.Sanin Rosai HospitalTottoriJapan
  5. 5.Japan Osteoporosis SocietyOsakaJapan
  6. 6.Hakuai HospitalTottoriJapan
  7. 7.Bibai Rosai HospitalHokkaidoJapan
  8. 8.Kawasaki Medical SchoolOkayamaJapan
  9. 9.Aoyama General HospitalAichiJapan
  10. 10.Hamamatsu Institute of Clinical Pharmacology and TherapeuticsHamamatsuJapan
  11. 11.Tokyo Metropolitan Geriatric Medical CenterTokyoJapan