Original Article

Osteoporosis International

, Volume 10, Issue 3, pp 183-192

A Double-Masked Multicenter Comparative Study Between Alendronate and Alfacalcidol in Japanese Patients with Osteoporosis

  • M. ShirakiAffiliated withResearch Institute and Practice for Involutional Diseases, Minamiazumi-gun, Nagano
  • , K. KushidaAffiliated withDepartment of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka
  • , M. FukunagaAffiliated withDepartment of Nuclear Medicine, Kawasaki Medical School, Kurashiki, Okayama
  • , H. KishimotoAffiliated withDepartment of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori
  • , M. TagaAffiliated withDepartment of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama
  • , T. NakamuraAffiliated withDepartment of Orthopedic Surgery, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka
  • , K. KanedaAffiliated withDepartment of Orthopedic Surgery, Hokkaido University School of Medicine, Sapporo
  • , H.  MinaguchiAffiliated withDepartment of Obstetrics and Gynecology, Yokohama City University School of Medicine, Yokohama
  • , T. InoueAffiliated withDepartment of Orthopedic Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka
    • , H. MoriiAffiliated withSecond Department of Internal Medicine, Osaka City University School of Medicine, Osaka
    • , A. TomitaAffiliated withDepartment of Laboratory Medicine, Aichi Medical University, Aichi-gun, Aichi
    • , K. YamamotoAffiliated withDepartment of Orthopedic Surgery, Faculty of Medicine, Tottori University, Yonago, Tottori
    • , Y. NagataAffiliated withResearch Institute and Practice for Involutional Diseases, Minamiazumi-gun, NaganoDepartment of Obstetrics and Gynecology, Faculty of Medicine, Kagoshima University, Kagoshima, Kagoshima
    • , M. NakashimaAffiliated withResearch Institute and Practice for Involutional Diseases, Minamiazumi-gun, NaganoDepartment of Pharmacology, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka
    • , H. OrimoAffiliated withResearch Institute and Practice for Involutional Diseases, Minamiazumi-gun, NaganoMinistry of Finance Tokyo Hospital, Tokyo, Japan
    • , The Alendronate Phase III Osteoporosis Treatment Research Group

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Abstract:

To evaluate the efficacy and safety of alendronate, a double-masked, active (alfacalcidol) controlled comparative study for 48 weeks was carried out in a total of 210 Japanese patients with osteoporosis. The doses of alendronate and alfacalcidol were 5 mg/day and 1 μg/day, respectively. The lumbar bone mineral density (LBMD) values observed at 12, 24, 36 and 48 weeks after the initiation of alendronate treatment were 3.53 ± 0.53%, 5.37 ± 0.62%, 5.87 ± 0.74% and 6.21 ± 0.59% (mean ± SE), respectively, higher than the baseline value. Corresponding values in the alfacalcidol group were 1.50 ± 0.43%, 0.69 ± 0.63%, 1.12 ± 0.60% and 1.36 ± 0.63%, respectively. There was a significant difference between the two groups at each time point (p<0.05 or p<0.001). The bone turnover markers were depressed during treatment in the alendronate group: −32.2% for alkaline phosphatase, −53.7% for N-terminal osteocalcin and −45.0% for urinary deoxypyridinoline compared with the corresponding baseline values. On the contrary, no notable changes in these parameters were observed in the alfacalcidol group. Treatment with alendronate caused a transient decrease in serum calcium concentrations associated with an increase in the serum level of intact parathyroid hormone. In contrast, treatment with alfacalcidol resulted in a tendency of these parameters to change in the opposite direction. No difference in fracture incidence between the two groups was observed. The overall safety of alendronate was comparable to that of alfacalcidol. In conclusion, although it was a relatively short-term study of 48 weeks, the results of the present study indicate that alendronate at the daily dose of 5 mg was effective in increasing LBMD and that no serious drug-related adverse events were observed in the alendronate-treated patients. Alendronate is more efficacious than alfacalcidol in increasing bone mineral density, although the mechanisms of the actions of the two drugs are apparently different.

Key words:Alendronate – Alfacalcidol – Bone mineral density – Double-masked comparative study – Osteoporosis