Journal of Bone and Mineral Metabolism

, Volume 25, Issue 2, pp 130–137 | Cite as

Clinical effect of bisphosphonate and vitamin D on osteoporosis: reappraisal of a multicenter double-blind clinical trial comparing etidronate and alfacalcidol

  • Takuo Fujita
  • Hajime Orimo
  • Tetsuo Inoue
  • Kiyoshi Kaneda
  • Minoru Sakurai
  • Rikushi Morita
  • Kichizo Yamamoto
  • Yoichi Sugioka
  • Akio Inoue
  • Kunio Takaoka
  • Itsuo Yamamoto
  • Yuichi Hoshino
  • Hiroshi Kawaguchi
ORIGINAL ARTICLE

Abstract

As inhibitors of bone resorption, bisphosphonates and vitamin D derivatives have been extensively used for the treatment of osteoporosis in various parts of the world, but the clinical effects of these two groups of agents have rarely been compared in detail. A multicenter, prospective, double-blind controlled study was started comparing the effects of etidronate and alfacalcidol (1-alpha-hydroxycholecalciferol) in 414 patients with established osteoporosis from 36 centers. Among these patients, 135 were given 400 mg etidronate daily at bedtime for 2 weeks followed by 10 weeks off treatment, and this cycle was repeated four times along with a placebo indistinguishable from the alfacalcidol capsule daily throughout the 48 weeks of study (Group A, High Dose Etidronate Group). In 133 patients, 200 mg etidronate was used instead of 400 mg (Group B, Low Dose Etidronate Group). In 138 patients, 1 µg alfacalcidol was given daily throughout the 48-week study period along with a placebo indistinguishable from the etidronate tablet in four separate periods of 2 weeks (Group C, Control Group). Dual-energy X-ray absorptiometry of the lumbar spine (L2–L4) was performed before the beginning of the study and every 12 weeks thereafter. Changes in spinal deformity were also assessed based on the lateral thoracic and lumbar spine X-ray films taken before and after the study. The lumbar spine bone mineral density (BMD) changes were +3.4% ± 0.6% (mean ± SEM) in Group A, +2.4% ± 0.5% in Group B, and −0.5% ± 0.4% in Group C, the former two being significantly higher than the last. New occurrence of spinal compression fracture was also significantly reduced in Group A compared to Group C. In patients without previous fracture at entry, incident fracture was 10.2% in Group C, but 0% in Groups A and B. In patients with prevalent fracture at entry, corresponding figures were 21.5% (Group C), 12.0% (Group A), and 13.2% (Group B), respectively. Alfacalcidol maintained lumbar spine BMD, preventing a decrease for 48 weeks, and etidronate significantly increased it further, demonstrating its usefulness in the treatment of established osteoporosis.

Key words

etidronate alfacalcidol osteoporosis DXA (dual energy X-ray absorptiometry) fracture 

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Copyright information

© Springer-Verlag Tokyo 2007

Authors and Affiliations

  • Takuo Fujita
    • 1
  • Hajime Orimo
    • 2
  • Tetsuo Inoue
    • 3
  • Kiyoshi Kaneda
    • 4
  • Minoru Sakurai
    • 5
  • Rikushi Morita
    • 6
  • Kichizo Yamamoto
    • 7
  • Yoichi Sugioka
    • 8
  • Akio Inoue
    • 9
  • Kunio Takaoka
    • 10
  • Itsuo Yamamoto
    • 11
  • Yuichi Hoshino
    • 12
  • Hiroshi Kawaguchi
    • 13
  1. 1.Calcium Research InstituteKatsuragi HospitalOsakaJapan
  2. 2.University of Health ScienceTokyoJapan
  3. 3.Aoyama General HospitalToyohashiJapan
  4. 4.Bibai Rosai HospitalBibaiJapan
  5. 5.Tohoku Central HospitalSendaiJapan
  6. 6.Shiga University of Medical Science HospitalOtsuJapan
  7. 7.Hakuai HospitalYonagoJapan
  8. 8.Kyushu Rosai HospitalFukuokaJapan
  9. 9.Dept. of Orthopedic SurgeryYanagawa Rehabilitation HospitalYanagawaJapan
  10. 10.Dept. of Orthopedic Surgery, Medical SchoolOsaka City University Graduate School of MedicineOsakaJapan
  11. 11.Yamamoto ClinicShigaJapan
  12. 12.Dept. of Orthopedic SurgeryJichi Medical SchoolTochigiJapan
  13. 13.Dept. of Orthopedic-Spinal Surgery, Graduate School of Medicine and Faculty of MedicineUniversity of TokyoTokyoJapan

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