Abstract | BACKGROUND: METHODS AND RESULTS: This 3 year randomized, double-blind, active comparator, superiority trial tested the efficacy of daily oral 0.75 μg eldecalcitol versus 1.0 μg alfacalcidol for prevention of osteoporotic fractures. 1054 osteoporotic patients 46 to 92 years old were randomly assigned 1:1 to receive eldecalcitol (n=528) or alfacalcidol (n=526). Patients were stratified by study site and serum 25-hydroxyvitamin D level. Patients with low serum 25-hydroxyvitamin D levels (<50 nmol/L) were supplemented with 400 IU/day vitamin D(3). Primary end point was incident vertebral fractures. Secondary end points included any non-vertebral fractures and change in bone mineral density and bone turnover markers. Compared with the alfacalcidol group, the incidence of vertebral fractures was lower in eldecalcitol group after 36 months of treatment (13.4 vs. 17.5%; hazard ratio, 0.74; predefined 90% confidence interval [CI], 0.56-0.97). Eldecalcitol reduced turnover markers and increased bone mineral density more strongly than alfacalcidol. Eldecalcitol reduced the incidence of three major non-vertebral fractures, which was due to a marked reduction in wrist fractures by a post-hoc analysis (1.1 vs. 3.6%; hazard ratio, 0.29; 95% CI, 0.11-0.77). Among the adverse events, the incidence of increase in serum and urinary calcium was higher in the eldecalcitol group, without any difference in glomerular filtration rate between the two groups. CONCLUSIONS:
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Authors | Toshio Matsumoto, Masako Ito, Yasufumi Hayashi, Takako Hirota, Yusuke Tanigawara, Teruki Sone, Masao Fukunaga, Masataka Shiraki, Toshitaka Nakamura |
Journal | Bone
(Bone)
Vol. 49
Issue 4
Pg. 605-12
(Oct 2011)
ISSN: 1873-2763 [Electronic] United States |
PMID | 21784190
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2011 Elsevier Inc. All rights reserved. |
Chemical References |
- Hormones
- Vitamin D
- Cholecalciferol
- 25-hydroxyvitamin D
- eldecalcitol
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Topics |
- Aged
- Aged, 80 and over
- Bone Density
(drug effects)
- Bone Remodeling
(drug effects)
- Cholecalciferol
(analogs & derivatives)
- Double-Blind Method
- Female
- Hormones
(blood)
- Humans
- Incidence
- Japan
(epidemiology)
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Osteoporotic Fractures
(blood, drug therapy, physiopathology, prevention & control)
- Risk Factors
- Spinal Fractures
(blood, drug therapy, epidemiology, physiopathology)
- Treatment Outcome
- Vitamin D
(analogs & derivatives, blood, pharmacology, therapeutic use)
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