drugset / Trial / NCT00144456
A New Active Vitamin D, ED-71 for Osteoporosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A prospective, randomized, double-blind study to compare the effect of ED-71 with that of alfacalcidol on fracture incidence
Timeline
- Start
- 2004-09
- Primary completion
- 2008-09
- Completion
- 2008-10
Outcome
Met primary endpoint
paper 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). PMID 21784190 ↗
release “significantly increased the bone mineral density (BMD) of osteoporosis patients compared with alfacalcidol in a Chinese Phase III study.” chugai-pharm.co.jp ↗
release “patients receiving eldecalcitol showed a statistically significant increase of BMD compared to those receiving alfacalcidol.” chugai-pharm.co.jp ↗
Publications
- Shiraki M, Saito H, Matsumoto T. Eldecalcitol normalizes bone turnover markers regardless of their pre-treatment levels. Curr Med Res Opin. 2012 Sep;28(9):1547-52. doi: 10.1185/03007995.2012.712506. Epub 2012 Aug 23.
- Matsumoto T, Ito M, Hayashi Y, Hirota T, Tanigawara Y, Sone T, Fukunaga M, Shiraki M, Nakamura T. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures--a randomized, active comparator, double-blind study. Bone. 2011 Oct;49(4):605-12. doi: 10.1016/j.bone.2011.07.011. Epub 2011 Jul 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alfacalcidol | Other / unclassified | 1 ug | Oral |
| Subject | Eldecalcitol | Small molecule | 0.75 ug | Oral |