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


    • Department of Orthopedic SurgeryHamamatsu University School of Medicine
  • Masataka Shiraki
    • Research Institute and Practice for Involutional Diseases
  • Toshitaka Nakamura
    • University of Occupational and Environmental Health
  • Hideaki Kishimoto
    • Sanin Rosai Hospital
  • Hirotoshi Morii
    • Japan Osteoporosis Society
  • Kichizo Yamamoto
    • Hakuai Hospital
  • Kiyoshi Kaneda
    • Bibai Rosai Hospital
  • Masao Fukunaga
    • Kawasaki Medical School
  • Tetsuro Inoue
    • Aoyama General Hospital
  • Mitsuyoshi Nakashima
    • Hamamatsu Institute of Clinical Pharmacology and Therapeutics
  • Hajime Orimo
    • Tokyo Metropolitan Geriatric Medical Center

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


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