Frontiers in vitamin D; Basic research and clinical application. The effects of eldecalcitol on bone mineral density and fracture prevention--Post hoc analysis
Abstract
We conducted a post-hoc analysis of the phase III clinical trial of eldecalcitol (in comparison with alfacalcidol) . Enrolled subjects were divided into subgroups according to age, vitamin D levels, prevalent vertebral fractures, and baseline lumbar bone mineral density (LBMD) . In the eldecalcitol group, LBMD increased more than 3% in 3 years, which was significantly higher than that in the alfacalcidol group in all 4 subgroups. Incidence of new vertebral fractures was lower in the eldecalcitol group than in the alfacalcidol group in each of the first 3 subgroups, and the difference between eldecalcitol and alfacalcidol was significant in the age group of 70 years and over. When we compared the fracture risk with the placebo group reported in the minodronic acid phase III fracture prevention trial, the reductions in relative risk in the alfacalcidol and eldecalcitol group were about 30% and 50%, respectively (not direct comparisons) . Eldecalcitol is beneficial for a wide range of patients with osteoporosis, since its effects of increasing BMD and preventing fractures were not impaired by age, vitamin D levels, prevalent vertebral fractures, or baseline BMD.
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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