| Item type |
文献 / Documents(1) |
| 公開日 |
2024-11-22 |
| アクセス権 |
|
|
アクセス権 |
open access |
|
アクセス権URI |
http://purl.org/coar/access_right/c_abf2 |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1016/j.bone.2011.07.011 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1016/j.bone.2011.07.011 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures : A randomized, active comparator, double-blind study |
|
言語 |
en |
| 著者 |
松本, 俊夫
Ito, Masako
Hayashi, Yasufumi
Hirota, Takako
Tanigawara, Yusuke
Sone, Teruki
Fukunaga, Masao
Shiraki, Masataka
Nakamura, Toshitaka
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Background: Eldecalcitol is an analog of 1,25-dihydroxyvitamin D3 that improves bone mineral density; however, the effect of eldecalcitol on the risk of fractures is unclear. The objective of this study is to examine whether eldecalcitol is superior to alfacalcidol in preventing osteoporotic fractures. This trial is registered with ClinicalTrials.gov, number NCT00144456.
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 D3. 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: Eldecalcitol is more efficacious than alfacalcidol in preventing vertebral and wrist fractures in osteoporotic patients with vitamin D sufficiency, with a safety profile similar to alfacalcidol. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Osteoporosis |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Vertebral fracture |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Wrist fracture |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Bone mineral density |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Active vitamin D |
| 書誌情報 |
en : Bone
巻 49,
号 4,
p. 605-612,
発行日 2011-07-19
|
| 収録物ID |
|
|
収録物識別子タイプ |
PISSN |
|
収録物識別子 |
87563282 |
| 収録物ID |
|
|
収録物識別子タイプ |
EISSN |
|
収録物識別子 |
18732763 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA10506985 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11521689 |
| 出版者 |
|
|
出版者 |
Elsevier Inc. |
|
言語 |
en |
| 権利情報 |
|
|
言語 |
en |
|
権利情報 |
Open access under CC BY-NC-ND license. |
| EID |
|
|
識別子 |
252839 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
bone_49_4_605.pdf (452 KB)
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