Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation.
Study Goal
The researchers aimed to determine whether eldecalcitol (a vitamin D analog) could increase bone mineral density (BMD) in osteoporotic patients with vitamin D insufficiency and low calcium intake, compared to alfacalcidol.
Results Summary
Eldecalcitol increased lumbar, total hip, and femoral neck BMD more than alfacalcidol after 12 months, regardless of baseline vitamin D status or calcium intake, without significant differences in adverse events or hypercalcemia incidence.
Population
265 Chinese osteoporotic patients with low calcium intake (<550 mg/day) and vitamin D insufficiency (mean serum 25(OH)D <43 nmol/L).
Effective Dosage
0.75 μg eldecalcitol or 1.0 μg alfacalcidol daily.
Duration
12 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Eldecalcitol | increase | bone mineral density (BMD) | vitamin D-sufficient osteoporotic subjects | - | increased | #1 |
Eldecalcitol | decrease | vertebral fractures | vitamin D-sufficient osteoporotic subjects | - | prevented | #2 |
Eldecalcitol | increase | lumbar BMD | Chinese osteoporotic patients | 2.05% higher than alfacalcidol group | increased | #3 |
Eldecalcitol | increase | total hip BMD | Chinese osteoporotic patients | 1.33% higher than alfacalcidol group | increased | #4 |
Eldecalcitol | increase | femoral neck BMD | Chinese osteoporotic patients | 1.78% higher than alfacalcidol group | increased | #5 |
Eldecalcitol | no change | BMD | Chinese osteoporotic patients | - | was not affected | #6 |
Eldecalcitol | increase | lumbar and hip BMD more than alfacalcidol | osteoporotic patients | - | increased | #7 |
Eldecalcitol | increase | BMD | osteoporotic patients | - | is effective in increasing | #8 |
- | decrease | baseline BMD | patients with lower calcium intake and serum 25(OH)D | - | tended to be lower | #9 |
- | no change | incidence of adverse events | Chinese osteoporotic patients | - | was not different | #10 |
edecalcitol | no change | incidence of hypercalcemia | Chinese osteoporotic patients | - | was not affected | #11 |
Eldecalcitol increased bone mineral density (BMD) and prevented vertebral fractures in vitamin D-sufficient osteoporotic subjects. However, the effect of eldecalcitol on BMD under vitamin D insufficiency is unknown. We examined the effect of eldecalcitol on BMD compared with alfacalcidol in osteoporotic patients without vitamin D or calcium supplementation. This is a randomized, double-blind, active comparator trial. 265 Chinese osteoporotic patients were randomly assigned to receive 0.75 μg eldecalcitol or 1.0 μg alfacalcidol for 12 months without vitamin D or calcium supplementation. Baseline calcium intakes were less than 550 mg/day and mean serum 25-hydroxyvitamin D [25(OH)D] was below 43 nmol/L in both groups. Baseline BMD tended to be lower in patients with lower calcium intake and serum 25(OH)D. Lumbar BMD increased by 2.05% higher in eldecalcitol than alfacalcidol group at 12 months. Total hip and femoral neck BMD also increased by 1.33 and 1.78%, respectively, in the eldecalcitol than the alfacalcidol group. The effect of eldecalcitol on BMD was not affected by serum 25(OH)D or calcium intake. The incidence of adverse events was not different between the two groups. Incidence of hypercalcemia in the edecalcitol group was not affected by serum 25(OH)D. In conclusion, baseline BMD tended to be lower in patients with low calcium intake and serum 25(OH)D. Eldecalcitol increased lumbar and hip BMD more than alfacalcidol regardless of serum 25(OH)D or calcium intake without vitamin D or calcium supplementation. These results suggest that eldecalcitol is effective in increasing the BMD of osteoporotic patients regardless of vitamin D status or calcium intake.Clinical Trial Registration number JAPIC CTI 152904.