AbstractVitamin D is a fat-soluble vitamin and exerts effects on skeletal and extraskeletal health in children and adults of all ages. Vitamin D insufficiency is related to low muscle strength, increasing body sway, falls in the elderly. Supplementation with vitamin D reduces risk of osteoporotic fracture, and improves muscle strength and postural balance to prevent the elderly from fall. The preferred vitamin D analog for daily supplementation is cholecalciferol (vitamin D3). The active form of vitamin D3 is 1,25-dihydroxy-vitamin D3. Alfacalcidol, calcitriol and eldecalcitol are used to treat osteoporosis in Japan. Randomized placebo-controlled, double-blinded clinical trial for osteoporotic subjects showed that eldecalcitol is more efficacious to increase bone mineral density and prevent vertebral and wrist fractures in osteoporotic patients with vitamin D sufficiency than alfacalcidol.PMID: 26529933 [Indexed for MEDLINE] Publication typeEnglish AbstractMeSH termsAccidental FallsBone Density/drug effectsDrug CombinationsHumansOsteoporosis/prevention & controlOsteoporotic Fractures/prevention & controlVitamin D/analogs & derivativesVitamin D/therapeutic use*SubstancesDrug CombinationsVitamin DMedicalVitamin D - MedlinePlus Health Information
Author information1Jubilant Biosys Ltd, Drug Discovery Unit, #96, 2nd Stage, Industrial Suburb Yeshwantpur, Bangalore, India. AbstractElocalcitol, which had been under development by BioXell SpA, is a synthetic derivative of vitamin D3 that regulates cell proliferation and apoptosis via its binding to the vitamin D receptor. In preclinical studies, elocalcitol inhibited the androgen-dependent and androgen-independent proliferation of benign prostatic hyperplasia (BPH) cells more potently than finasteride, a 5alpha-reductase inhibitor. In a phase IIb trial in patients with BPH, treatment with elocalcitol resulted in a significantly reduced prostate volume compared with placebo; irritative urinary symptoms (frequency, urgency and nocturia) and urodynamic parameters were comparable to the alpha1-adrenoceptor antagonist tamsulosin. In a phase IIa trial in patients with prostatitis, elocalcitol significantly reduced levels of IL-8 in semen, suggesting improved quality and forward motility of sperm.
However, phase IIb trial data from patients with overactive bladder (OAB) were less promising: elocalcitol failed to meet the primary endpoint despite demonstrating good efficacy in a phase IIa trial. Based largely on these disappointing data, BioXell decided to terminate all further clinical development of elocalcitol, including an uncompleted phase IIa trial in patients with male infertility. Given the novel mechanism of action, efficacy profile and improved tolerability of elocalcitol over existing classes of drugs, the compound could have potentially added to the armamentarium in the expanding therapeutic markets of BPH, OAB and male infertility. This possibility appears to have been negated by BioXell's recent decision to terminate all further development of elocalcitol.PMID: 19517319 [Indexed for MEDLINE] MeSH termsAnimalsApoptosis/drug effectsCalcitriol/adverse effectsCalcitriol/analogs & derivatives*Calcitriol/pharmacologyCalcitriol/therapeutic useCell Proliferation/drug effectsClinical Trials, Phase II as TopicFemaleHumansInfertility, Male/drug therapyInfertility, Male/physiopathologyMaleProstatic Hyperplasia/drug therapyProstatic Hyperplasia/physiopathologyReceptors, Calcitriol/drug effects*Receptors, Calcitriol/metabolismUrinary Bladder, Overactive/drug therapyUrinary Bladder, Overactive/physiopathologySubstancesBXL628Receptors, CalcitriolCalcitriolOther Literature SourcesCited by Patents in - The LensMedicalBenign Prostatic Hyperplasia - Genetic Allianceinfertility - Genetic AllianceMiscellaneous1
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