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Journal of Bone and Mineral Metabolism

, Volume 30, Issue 3, pp 349–358 | Cite as

Alfacalcidol-supplemented raloxifene therapy has greater bone-sparing effect than raloxifene-alone therapy in postmenopausal Japanese women with osteoporosis or osteopenia

  • Itsuo GoraiEmail author
  • Shin Hattori
  • Yaku Tanaka
  • Yasuhisa Iwaoki
Original Article

Abstract

Vitamin D insufficiency is prevalent in osteopenic and osteoporotic postmenopausal women. The persistent increase in circulating parathyroid hormone (PTH) caused by vitamin D insufficiency reduces bone density response to antiresorptive agents in these postmenopausal women. It is not well known whether administration of raloxifene might increase serum PTH secondary to the suppression of serum calcium in postmenopausal women with osteopenia or osteoporosis. We tried to assess whether raloxifene might affect serum PTH and whether the addition of alfacalcidol to raloxifene therapy could have favorable effects on bone mineral density (BMD) and bone turnover as compared to raloxifene-alone therapy in postmenopausal Japanese women with osteoporosis or osteopenia (≤2.0 SD based on young Japanese women). A total of 169 subjects were randomly assigned to groups receiving 60 mg raloxifene (R), or 1 μg alfacalcidol (D), or a combination of both (R + D) for 2 years. Serum levels of 25-hydroxyvitamin D [25(OH)D] were measured at randomization. The modified ‘intention to treat’ method was used. We compared the groups using a Tukey–Kramer test for changes in L- and TH-BMD and calcium metabolism when significant differences were found using one-way ANOVA. The parameters in each group during the experimental period were analyzed by means of paired t tests. Baseline 25(OH)D and i-PTH were 23.7 ng/ml and 38.4 pg/ml, respectively. At 6 months, i-PTH demonstrated a significant increase (+21.0%) in the R-group whereas significant decreases in i-PTH were observed in the D-group and combination-group (−15.9 and −8.9%, respectively). There were significant increases in L-BMD in the R + D-group (+4.1% at 1 year and +4.7% at 2 years, P < 0.0001) and in the R-group (+2.9% at 1 year and +2.8% at 2 years, P < 0.001), but the difference between the groups did not reach a significant level. Vitamin D status at randomization did not affect the subsequent BMD response in coadministration of alfacalcidol with raloxifene. Supplementation with alfacalcidol to raloxifene therapy demonstrates a greater bone-sparing effect by suppressing the secondary increment of serum PTH than when raloxifene is used alone.

Keywords

Raloxifene Alfacalcidol Bone density Vitamin D PTH 

Notes

Conflict of interest

I.G. has received honoraria for lectures from Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.

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Copyright information

© The Japanese Society for Bone and Mineral Research and Springer 2011

Authors and Affiliations

  • Itsuo Gorai
    • 1
    • 2
    Email author
  • Shin Hattori
    • 1
    • 3
  • Yaku Tanaka
    • 1
    • 2
  • Yasuhisa Iwaoki
    • 4
  1. 1.Department of Obstetrics and GynecologyInternational University of Health and Welfare Atami HospitalAtamiJapan
  2. 2.Department of Obstetrics and GynecologyHori HospitalYokohamaJapan
  3. 3.Department of Obstetrics and GynecologyOdawara Municipal HospitalOdawaraJapan
  4. 4.Department of Obstetrics and GynecologyJA Yoshida General HospitalHiroshimaJapan

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