TY - JOUR
T1 - A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures - A randomized, active comparator, double-blind study
AU - Matsumoto, Toshio
AU - Ito, Masako
AU - Hayashi, Yasufumi
AU - Hirota, Takako
AU - Tanigawara, Yusuke
AU - Sone, Teruki
AU - Fukunaga, Masao
AU - Shiraki, Masataka
AU - Nakamura, Toshitaka
N1 - Funding Information:
The present study was sponsored by Chugai Pharmaceutical Co., Ltd. The sponsor of the study participated in study design, data collection, data analyses, data interpretation, and writing of the report. The sponsor supplied the study medication, and had responsibility for data collection and quality control. The corresponding author had full access to all the data in the study and had responsibility for the decision to submit for publication.
PY - 2011/10
Y1 - 2011/10
N2 - Background: Eldecalcitol is an analog of 1,25-dihydroxyvitamin D 3 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 3year randomized, double-blind, active comparator, superiority trial tested the efficacy of daily oral 0.75μg eldecalcitol versus 1.0μg alfacalcidol for prevention of osteoporotic fractures. 1054 osteoporotic patients 46 to 92years 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 (<50nmol/L) were Supplemented with 400IU/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 36months 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.
AB - Background: Eldecalcitol is an analog of 1,25-dihydroxyvitamin D 3 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 3year randomized, double-blind, active comparator, superiority trial tested the efficacy of daily oral 0.75μg eldecalcitol versus 1.0μg alfacalcidol for prevention of osteoporotic fractures. 1054 osteoporotic patients 46 to 92years 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 (<50nmol/L) were Supplemented with 400IU/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 36months 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.
KW - Active vitamin D
KW - Bone mineral density
KW - Osteoporosis
KW - Vertebral fracture
KW - Wrist fracture
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U2 - 10.1016/j.bone.2011.07.011
DO - 10.1016/j.bone.2011.07.011
M3 - Article
C2 - 21784190
AN - SCOPUS:80052278079
SN - 8756-3282
VL - 49
SP - 605
EP - 612
JO - Bone
JF - Bone
IS - 4
ER -
