Abstract
Eldecalcitol (1α,25[OH]2-2β-(3-hydroxypropyloxy)vitamin D3; ED-71; Edirol®) is an orally administered analogue of active vitamin D (calcitriol) that is available in Japan for the treatment of osteoporosis at a dosage of 0.75 µg/day.
In a randomized, double-blind, placebo-controlled, dose-ranging trial, eldecalcitol reduced markers of bone turnover significantly more than placebo. Similarly, in a randomized, double-blind comparison with the calcitriol prodrug, alfacalcidol 1.0µg/day, eldecalcitol 0.75µg/day produced significantly greater reductions in markers of bone turnover and had a positive effect on femoral biomechanical properties. In both trials, eldecalcitol treatment was associated with an increase in bone mineral density (BMD), whereas patients who received the comparators generally had a reduction in BMD.
In the comparison with alfacalcidol, eldecalcitol significantly reduced the 3-year incidence of vertebral fractures (primary endpoint), with an absolute risk reduction of 4.1% over this period, representing a relative risk reduction of 26%. There was no significant difference in the rate of non-vertebral fractures.
In both trials, increases in blood calcium (to >2.6 mmol/L) and urinary calcium (to >0.1 mmol/L glomerular filtrate) were the most clinically important treatment-emergent adverse events. In the comparison with alfa-calcidol over 36 months of treatment, 21.0% and 13.5% of eldecalcitol 0.75µg/day and alfacalcidol 1.0µg/day recipients had increased blood calcium, whereas hypercalcaemia (defined as a serum calcium >2.9 mmol/L) occurred in 0.4% and urolithiasis in 1.3% of eldecalcitol recipients.
Eldecalcitol is an efficacious treatment for patients with osteoporosis that should be further investigated in head-to-head trials with other recommended first-line pharmacological treatments.
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References
Abe M, Tsuji N, Takahashi F, et al. Overview of the clinical pharmacokinetics of eldecalcitol, a new active vitamin D3 derivative. Jpn Pharmacol Ther 2011; 39(3): 261–74
Miyata K, Abe M, Terao K, et al. Pharmacokinetics of eldecalcitol in primary osteoporosis patients: randomized, double-blind, multicentre, long-term phase III clinical study. Jpn Pharmacol Ther 2011; 39(3): 299–307
Matsumoto T, Takano T, Yamakido S, et al. Comparison of the effects of eldecalcitol and alfacalcidol on bone and calcium metabolism. J Steroid Biochem Mol Biol 2010 Jul; 121(1–2): 261–4
Kubodera N, Tsuji N, Uchiyama Y, et al. A new active vitamin D analog, ED-71, causes increase in bone mass with preferential effects on bone in osteoporotic patients. J Cell Biochem 2003 Feb 1; 88(2): 286–9
Uchiyama Y, Higuchi Y, Takeda S, et al. ED-71, a vitamin D analog, is a more potent inhibitor of bone resorption than alfacalcidol in an estrogen-deficient rat model of osteoporosis. Bone 2002 Apr; 30(4): 582–8
Matsumoto T, Miki T, Hagino H, et al. A new active vitamin D, ED-71, increases bone mass in osteoporotic patients under vitamin D supplementation: a randomized, double-blind, placebo-controlled clinical trial. J Clin Endocrinol Metab 2005 Sep; 90(9): 5031–6
Matsumoto T, Ito M, Hayashi Y, et al. A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures: a randomized, active comparator, double-blind study. Bone. Epub 2011 Jul 19
Ito M, Nakamura T, Fukunaga M, et al. Effect of eldecalcitol, an active vitamin D analog, on hip structure and bio-mechanical properties: 3D assessment by clinical CT. Bone 2011 Sep; 49(3): 328–34
Sanford M, McCormack PL. Eldecalcitol: a review of its use in the treatment of osteoporosis. Drugs 2011; 71(13): 1755–70
Acknowledgements and Disclosures
The full text article[9] from which this spotlight was derived was reviewed by: B. Cortet, Department of Rheumatology, University Hospital of Lille, Lille, France; E. Franek, Department of Internal Medicine, Endocrinology and Diabetology, Central Clinical Hospital, Ministry of Internal Affairs and Administration, Warsaw, Poland; J. Iwamoto, Institute for Integrated Sports Medicine, Keio University School of Medicine, Keio University, Tokyo, Japan; M. Kleerekoper, Department of Internal Medicine, St Joseph Mercy Hospital, Ann Arbor, MI, USA.
The manufacturer of the agent under review was offered an opportunity to comment on the original article[9] during the peer review process; changes based on any comments received were made by the authors on the basis of scientific and editorial merit. The preparation of the original article and this spotlight was not supported by an external funding.
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Adapted and reproduced from the original article published in Drugs 2011; 71 (13): 1755–70.
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Sanford, M., McCormack, P.L. Spotlight on Eldecalcitol in Osteoporosis. Drugs Aging 29, 69–71 (2012). https://doi.org/10.2165/11207790-000000000-00000
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DOI: https://doi.org/10.2165/11207790-000000000-00000