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Archives of Osteoporosis

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Open Access 01-12-2022 | Osteoporosis | Original Article

Overview of the clinical efficacy and safety of eldecalcitol for the treatment of osteoporosis

Authors: Lijia Cui, Weibo Xia, Chuan Yu, Shuangshuang Dong, Yu Pei

Published in: Archives of Osteoporosis | Issue 1/2022

Abstract

Summary

Eldecalcitol (ELD) is a new oral analog of the active form of vitamin D with anti-resorptive properties. We conducted a meta-analysis to investigate the efficacy and safety of ELD in osteoporosis. Compared with alfacalcidol, ELD significantly lowered vertebral facture risk, increased bone mineral density, but also had a higher risk of hypercalciuria.

Purpose

This study aimed to investigate the efficacy and safety of eldecalcitol (ELD) in osteoporosis by examining fracture rates, bone mineral density (BMD), bone turnover markers, and adverse events as outcomes.

Methods

PubMed, EMBASE, and Cochrane Library were searched up to July 20, 2020, to identify eligible randomized controlled trials. The odds ratio (OR) or weighted mean difference (WMD) with 95% confidence interval was calculated by the random-effects model.

Results

ELD significantly increased lumbar BMD (WMD: 2.80; 95% CI: 1.60, 4.00; P < 0.001, 2 studies involved), total hip BMD (WMD: 2.11; 95% CI: 0.68, 3.55; P = 0.004, 2 studies involved), and femoral neck BMD (WMD: 1.78; 95% CI: 0.76, 2.79; P = 0.001, 1 study involved) compared with alfacalcidol. Moreover, ELD caused a significantly lower rate of vertebral fracture (OR: 0.52; 95% CI: 0.29–0.95; P = 0.034, 2 studies involved) than alfacalcidol, but did not lower the rate of non-vertebral facture (OR: 0.44; 95% CI: 0.06–3.05; P = 0.405, 2 studies involved) compared with alfacalcidol. ELD significantly reduced the percentage change in bone-specific alkaline phosphatase (WMD: − 15.40; 95% CI: − 20.30, − 10.60; P < 0.001, 1 study involved) and serum type I collagen C-telopeptide (WMD: − 38.50; 95% CI: − 50.00, − 27.10; P < 0.001, 1 study involved) as compared with alfacalcidol. ELD was also associated with higher risk of hypercalciuria compared with alfacalcidol (OR: 1.64; 95% CI: 1.22, 2.20; P = 0.001, 2 studies involved).

Conclusions

This systematic review indicated that ELD was superior than alfacalcidol for improving vertebral fracture risk and BMD. Further large-scale trials should be conducted to verify the long-term effects and safety of ELD in osteoporosis.

Prospero registration number

CRD42020147518.

Available only for authorised users

Reymondier A, Caillet P, Abbas-Chorfa F et al (2013) MENOPOST–calcium and vitamin D supplementation in postmenopausal osteoporosis treatment: a descriptive cohort study. Osteoporosis Int 24:559–566. https://doi.org/10.1007/s00198-012-1999-5CrossRef

Tamaki J, Iki M, Sato Y et al (2017) Total 25-hydroxyvitamin D levels predict fracture risk: results from the 15-year follow-up of the Japanese Population-based Osteoporosis (JPOS) Cohort Study. Osteoporosis Int 28:1903–1913. https://doi.org/10.1007/s00198-017-3967-6CrossRef

Bouillon R, Okamura WH, Norman AW (1995) Structure-function relationships in the vitamin D endocrine system. Endocrine Rev 16:200–257. https://doi.org/10.1210/edrv-16-2-200CrossRef

Xu Z, Fan C, Zhao X, Tao H (2016) Treatment of osteoporosis with eldecalcitol, a new vitamin D analog: a comprehensive review and meta-analysis of randomized clinical trials. Drug Des Devel Ther 10:509–517. https://doi.org/10.2147/DDDT.S84264CrossRefPubMedPubMedCentral

Noguchi Y, Kawate H, Nomura M et al (2013) Eldecalcitol for the treatment of osteoporosis. Clin Interv Aging 8:1313–1321. https://doi.org/10.2147/CIA.S49825CrossRefPubMedPubMedCentral

Sanford M, McCormack PL (2011) Eldecalcitol. a review of its use in the treatment of osteoporosis. Drugs 71:1755–1770. https://doi.org/10.2165/11206790-000000000-00000CrossRefPubMed

Sanford M, McCormack PL (2012) Spotlight on eldecalcitol in osteoporosis. Drugs Aging 29:69–71. https://doi.org/10.2165/11207790-000000000-00000CrossRefPubMed

Panic N, Leoncini E, de Belvis G et al (2013) Evaluation of the endorsement of the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement on the quality of published systematic review and meta-analyses. PLoS ONE 8:e83138. https://doi.org/10.1371/journal.pone.0083138CrossRefPubMedPubMedCentral

Lang B, Zhang L, Li F et al (2019) Comparison of the efficacy and safety of remifentanil versus different pharmacological approaches on prevention of etomidate-induced myoclonus: a meta-analysis of randomized controlled trials. Drug Des Dev Ther 13:1593–1607. https://doi.org/10.2147/DDDT.S200200CrossRef

10.

Ades AE, Lu G, Higgins JP (2005) The interpretation of random-effects metaanalysis in decision models. Med Decis Making 25:646–654. https://doi.org/10.1177/0272989X05282643CrossRefPubMed

11.

Deeks JJ, Higgins JPT, Altman DG (2008) Analyzing data and undertaking meta-analyses. In: Higgins J, Green S (ed) Cochrane Handbook for Systematic Reviews of Interventions 5.0.1., Chapter 9. The Cochrane Collaboration, Oxford

12.

Higgins JPT, Thompson SG, Deeks JJ et al (2003) Measuring inconsistency in meta-analyses. BMJ 2003(327):557–560. https://doi.org/10.1136/bmj.327.7414.557CrossRef

13.

Matsumoto T, Miki T, Hagino H et al (2005) 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 90:5031–5036. https://doi.org/10.1210/jc.2004-2552CrossRefPubMed

14.

Matsumoto T, Ito M, Hayashi Y et al (2011) A new active vitamin D3 analog, eldecalcitol, prevents the risk of osteoporotic fractures–a randomized, active comparator, double-blind study. Bone 49:605–612. https://doi.org/10.1016/j.bone.2011.07.011CrossRefPubMed

15.

Sakai A, Ito M, Tomomitsu T et al (2015) Efficacy of combined treatment with alendronate (ALN) and eldecalcitol, a new active vitamin D analog, compared to that of concomitant ALN, vitamin D plus calcium treatment in Japanese patients with primary osteoporosis. Osteoporosis Int 26:1193–1202. https://doi.org/10.1007/s00198-014-2991-zCrossRef

16.

Saito K, Miyakoshi N, Matsunaga T et al (2016) Eldecalcitol improves muscle strength and dynamic balance in postmenopausal women with osteoporosis: an open-label randomized controlled study. J Bone Miner Metab 34:547–554. https://doi.org/10.1007/s00774-015-0695-xCrossRefPubMed

17.

Nakatoh S (2018) Effect of osteoporosis medication on changes in bone mineral density and bone turnover markers after 24-month administration of daily teriparatide: comparison among minodronate, raloxifene, and eldecalcitol. J Bone Miner Metab 36:221–228. https://doi.org/10.1007/s00774-017-0829-4CrossRefPubMed

18.

Suzuki T, Nakamura Y, Tanaka M et al (2018) Comparison of the effects of denosumab with either active vitamin D or native vitamin D on bone mineral density and bone turnover markers in postmenopausal osteoporosis. Mod Rheumatol 28:376–379. https://doi.org/10.1080/14397595.2017CrossRefPubMed

19.

Uenishi K, Tokiwa M, Kato S et al (2018) Correction to: Stimulation of intestinal calcium absorption by orally administrated vitamin D3 compounds: a prospective open-label randomized trial in osteoporosis. Osteoporos Int 29:1225. https://doi.org/10.1007/s00198-018-4449-1CrossRefPubMedPubMedCentral

20.

Jiang Y, Tang H, Ma X et al (2019) Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation. J Bone Miner Metab. https://doi.org/10.1007/s00774-019-01009-9.10.1007/s00774-019-01009-9CrossRefPubMed

21.

Miyata K, Abe M, Terao K et al (2011) Pharmacokinetics of eldecalcitol in primary osteoporosis patients: randomized, double-blind, multicentre, long-term phase III clinical study. Jpn Pharmacol Ther 39:299–307

22.

Kubodera N, Tsuji N, Uchiyama Y et al (2003) A new active vitamin D analog, ED-71, causes increase in bone mass with preferential effects on bone in osteoporotic patients. J Cell Biochem 88:286–289. https://doi.org/10.1002/jcb.10346CrossRefPubMed

23.

Matsumoto T, Takano T, Yamakido S et al (2010) Comparison of the effects of eldecalcitol and alfacalcidol on bone and calcium metabolism. J Steroid Biochem Mol Biol 121:261–264. https://doi.org/10.1016/j.jsbmb.2010.03.035CrossRefPubMed

24.

Zhao Q, Liu H, Jiang J et al (2018) Non-compartmental pharmacokinetics and safety of single-dose eldecalcitol (ED-71) in healthy Chinese adult males. Clin Drug Invest 38:901–908. https://doi.org/10.1007/s40261-018-0682-9CrossRef

25.

Iba K, Sonoda T, Takada J et al (2017) Further significant effects of eldecalcitol on bone resorption markers and bone mineral density in postmenopausal osteoporosis patients having undergone long-term bisphosphonate treatment. J Bone Miner Metab 35:171–176. https://doi.org/10.1007/s00774-016-0738-yCrossRefPubMed

26.

Sakai S, Endo K, Takeda S et al (2012) Combination therapy with eldecalcitol and alendronate has therapeutic advantages over monotherapy by improving bone strength. Bone 50:1054–1063. https://doi.org/10.1016/j.bone.2012.02.005CrossRefPubMed

27.

Takeda S, Sakai S, Shiraishi A et al (2013) Combination treatment with eldecalcitol (ED-71) and raloxifene improves bone mechanical strength by suppressing bone turnover and increasing bone mineral density in ovariectomized rats. Bone 53:167–173. https://doi.org/10.1016/j.bone.2012.12.001CrossRefPubMed

Title: Overview of the clinical efficacy and safety of eldecalcitol for the treatment of osteoporosis
Authors: Lijia Cui
Weibo Xia
Chuan Yu
Shuangshuang Dong
Yu Pei
Publication date: 01-12-2022
Publisher: Springer London
Keywords: Osteoporosis
Osteoporosis
Published in: Archives of Osteoporosis / Issue 1/2022
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI: https://doi.org/10.1007/s11657-022-01071-3

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Overview of the clinical efficacy and safety of eldecalcitol for the treatment of osteoporosis

Abstract

Summary

Purpose

Methods

Results

Conclusions

Prospero registration number

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Summary

Purpose

Methods

Results

Conclusions

Prospero registration number

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