Matsumoto T et al. – 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.

Methods

• This 3year 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 92years old were randomly assigned 1:1 to receive eldecalcitol (n=528) or alfacalcidol (n=526).

Results

• 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 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 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.