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

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

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Gorai, Itsuo Hattori, Shin Tanaka, Yaku Iwaoki, Yasuhisa
Spatial Coverage	Japan
Description	Country affiliation: Japan Author Affiliation: Gorai I ( Department of Obstetrics and Gynecology, International University of Health and Welfare Atami Hospital, Atami, Shizuoka, 413-0012, Japan. i.gorai@hori-h.or.jp)
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.
File Format	HTM / HTML
ISSN	09148779
Issue Number	3
Volume Number	30
e-ISSN	14355604
Journal	Journal of Bone and Mineral Metabolism
Language	English
Publisher	Springer
Publisher Date	2012-05-01
Publisher Place	Japan
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Asian Continental Ancestry Group Bone And Bones Pathology Dietary Supplements Hydroxycholecalciferols Therapeutic Use Organ Sparing Treatments Osteoporosis, Postmenopausal Drug Therapy Raloxifene Aged Aged, 80 And Over Bone Density Drug Effects Bone Density Conservation Agents Pharmacology Physiopathology Calcium Blood Collagen Type I Urine Demography Drug Therapy, Combination Female Hip Humans Japan Lumbar Vertebrae Middle Aged Parathyroid Hormone Peptides Postmenopause Journal Article Multicenter Study Randomized Controlled Trial
Content Type	Text
Resource Type	Article
Subject	Orthopedics and Sports Medicine Endocrinology, Diabetes and Metabolism Endocrinology

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

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