Delving into the Latest Updates on Alfacalcidol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(5Z,7E)-9,10-seco-5,7,10(19)-cholestatrien-1α,3β-diol, 1-hydroxycholecalciferol, 1alpha-hydroxycholecalciferol

+ [27]

Target

VDR

Mechanism

VDR agonists(Vitamin D receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

HypocalcemiaOsteomalaciaVitamin D Deficiency+ [3]

Inactive Indication-

Originator Organization

LEO Pharma A/S

Active Organization

Teijin Pharma Ltd.

Chugai Pharmaceutical Co., Ltd.

Leo Pharma, Inc.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1978),

Chronic Kidney Disease-Mineral and Bone DisorderHypoparathyroidismOsteoporosis

Regulation-

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Structure

Molecular FormulaC27H44O2

InChIKeyOFHCOWSQAMBJIW-AVJTYSNKSA-N

CAS Registry41294-56-8

This study aims to investigate the potential improvement in muscle function, compared to the placebo group, through the concurrent administration of denosumab and alfacalcidol over a one-year period in postmenopausal women with functional sarcopenia and osteoporosis aged 65 and older. The study is planned as a double-blinded randomized controlled trial, intending to recruit a total of 340 participants. Primary outcome is the improvement in SPPB score of 0.5 or more compared to the control group.

Start Date13 Feb 2024

Sponsor / Collaborator

Yonsei University

NCT05505253 / CompletedPhase 3IIT

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

Start Date01 Nov 2020

Sponsor / Collaborator

Universitas Padjadjaran

NCT04967469 / CompletedNot ApplicableIIT

Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital

This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy

Start Date01 Sep 2020

Sponsor / Collaborator

Rajavithi Hospital

100 Clinical Results associated with Alfacalcidol

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100 Translational Medicine associated with Alfacalcidol

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100 Patents (Medical) associated with Alfacalcidol

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1,345

Literatures (Medical) associated with Alfacalcidol

01 Dec 2024·Hormones

A toddler with severe vitamin D-dependent rickets type 1 A (VDDR1A), hungry bone syndrome, and severe RSV infection: presentation and therapeutic challenges

Article

Author: Vakali, Eleni ; Karavanaki, Kyriaki ; Sakou, Irini-Ikbale ; Fryssira, Elena ; Vlachopapadopoulou, Elpis ; Paltoglou, George ; Economou, Stavroula ; Statha, Eleni ; Doulgeraki, Artemis ; Soldatou, Alexandra

BACKGROUNDVitamin D-dependent rickets type 1 A (VDDR1A) is an autosomal recessive disorder due to mutations in the CYP27B1 gene which result in inability to generate 1,25(OH)₂D.CASE PRESENTATIONAn 18-month-old boy with VDDR1A presented with hypotonia and respiratory distress. He had been diagnosed 2 months earlier, having been evaluated for stunted growth, hypotonia, and delayed developmental milestones. He was stabilized with oxygen and bronchodilators for his bronchiolitis and high doses of alfacalcidol, calcium, and phosphate supplements for his hungry bone syndrome. Of note, the patient sustained upper limb fractures after a fall from his bed during admission. Overall, he had a protracted disease course; however, his bone profile gradually improved and he steadily recovered.CONCLUSIONVDDR1A causes failure to thrive, hypotonia, and increased fracture risk and may complicate the clinical course of lower respiratory tract infections. Furthermore, management of hungry bone syndrome requires supraphysiologic doses of vitamin D metabolites and calcium.

01 Nov 2024·Radiology Case Reports

Pseudohypoparathyroidism leading to bilateral hip fracture: A case report

Article

Author: Ahmad, Rana Uzair ; Ashraf, Muhammad Fawad ; Daim, Safi Ur Rehman ; Aziz, Nouman ; Ashraf, Muhammad Aizaz

Pseudohypoparathyroidism (PHP) is a group of disorders characterized by end-organ resistance to parathyroid hormone (PTH), resulting in high serum PTH, low calcium, and high phosphate levels. Among its 5 subtypes, PHP type 1a is the most common and leads to hereditary osteodystrophy, marked by short stature, short metacarpals, and electrolyte abnormalities such as hyperphosphatemia and hypocalcemia, which can cause tetany and seizures. Rarely, PHP patients can experience pathological fractures of long bones. This report discusses a 22-year-old female with PHP who presented with myoclonic seizures and bilateral hip fractures. Initial symptoms included fits, flank pain, and later, leg weakness. Diagnosis was based on clinical history, elevated serum PTH, low calcium, high phosphate, bilateral cataracts, hypothyroidism, basal ganglia calcification, and family history. Treatment began with IV calcium, followed by alfacalcidol, oral calcium, and antibiotics, leading to symptom remission. Hip fractures were managed with a POP cast and later closed reduction. The patient was discharged with calcium and 1,25 dihydroxy Vitamin D supplementation and scheduled for regular follow-up.

31 Oct 2024·Journal of Nutritional Science and Vitaminology

Alfacalcidol-Induced Kidney Injury in Patients with Severe Motor and Intellectual Disabilities

Article

Author: KODUKA, Mari ; HATTORI, Kiyomi ; OTOBE, Yoshihiro ; HASEGAWA, Yuka ; NAKASHIMA, Hideaki ; UEMURA, Osamu

Patients with severe motor and intellectual disabilities (SMID) often experience insufficient physical activity, leading to osteoporosis. The active form of vitamin D is commonly prescribed for the prevention or treatment of osteoporosis. We observed four cases of kidney injury believed to be associated with the administration of 1α-OH vitamin D (alfacalcidol) preparations. This study employed a case series design to investigate change in kidney function in SMID patients following administration or discontinuation of alfacalcidol. We retrospectively analyzed data of 23 SMID patients (sex: 10 males, 13 females; age range: 27 to 74 y), and assessed kidney function, serum calcium, and albumin levels. Data was grouped into A: 16 cases collected both before starting alfacalcidol administration and during alfacalcidol administration; and into B: 11 cases collected during alfacalcidol administration and after discontinuation of alfacalcidol administration. Of the 23 patients, four were assigned into both group A and group B. Of the 16 cases in group A, six showed ≥30% decreased kidney function. Of the 11 cases in group B, the median values of modified Cr-eGFR were 43.0 and 65.1 mL/min/1.73 m², respectively (p=0.008), indicating a significant improvement in kidney function. It is essential for practitioners to understand that osteoporosis may ordinarily occur in SMID patients due to reduced bone stimulation. Thus caution must be exercised when administering active vitamin D preparations to this population, as they carry a risk of kidney organ damage despite having no direct effect on bone health.

100 Deals associated with Alfacalcidol

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External Link

KEGG	Wiki	ATC	Drug Bank
D01518	Alfacalcidol	A11CC03	DB01436

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypocalcemia	JP	Teijin Pharma Ltd.	29 May 1987
Osteomalacia	JP	Teijin Pharma Ltd.	29 May 1987
Vitamin D Deficiency	JP	Chugai Pharmaceutical Co., Ltd.	25 Oct 1980
Chronic Kidney Disease-Mineral and Bone Disorder	-	Leo Pharma, Inc.	01 Jan 1978
Hypoparathyroidism	-	Leo Pharma, Inc.	01 Jan 1978
Osteoporosis	-	Leo Pharma, Inc.	01 Jan 1978

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MO1020 (ERA2021)	Not Applicable	Hyperparathyroidism, Secondary	26	Calcitriol	(jvgwtmuhqw) = cmrbppqacd skexmghiwq (dsycybcrvo ) View more	Positive	29 May 2021
				Alfacalcidol	(jvgwtmuhqw) = hgaodxkupv skexmghiwq (dsycybcrvo ) View more
Pubmed \| J Clin Endocrinol Metab	Not Applicable	Hypoparathyroidism	-	Alfacalcidol	hglnfgplod(ibpcbdbuee) = zrqjkstqmv igozinovav (rfarezoiaw ) View more	-	22 Feb 2021
				Calcitriol	hglnfgplod(ibpcbdbuee) = mbbqsgkfbd igozinovav (rfarezoiaw ) View more
NCT04085770 (Pubmed \| Med Lett Drugs Ther)	Phase 4	-	86	Alfacalcidol 2 μg/d	kkqnjcntmg(dpxivnuogs): hazard ratio = 1.61 (95% CI, 1.77 - 2.81), P-Value = 0.041 View more	-	01 Jan 2021
				Alfacalcidol (Control group)
NCT02993302 (CTgov)	Phase 2	Graves Disease	25	1α-D3+PTU (PTU + Oral 1α-D3)	mjyzucfxsx(wkaluafjgm) = zqtqrsytrc afhkmtwnxr (qwadqrfcng, vzhgktjexp - xnlykzwety) View more	-	20 Feb 2020
				Placebos+PTU (PTU + Placebos)	mjyzucfxsx(wkaluafjgm) = obdbulwmas afhkmtwnxr (qwadqrfcng, jmmxslnynb - ldyhomjktn) View more
ESPE2019	Not Applicable	Pseudohypoparathyroidism Type 2	-	Alfacalcidol	(dmfxyvnuvg) = yrfnoaaiar dlyaepwlgp (wbqvquorxt ) View more	-	19 Sep 2019
				Calcium supplements	(dmfxyvnuvg) = kunyarfjeu dlyaepwlgp (wbqvquorxt ) View more
SP338 (ERA2019)	Not Applicable	Chronic Kidney Diseases PTH \| Klotho	90	Parycalcitol 1 mg/day	(msshpxbfpq) = lrlfmnmxkq wvamuuixjt (zztliuouqy ) View more	Positive	13 Jun 2019
				Alfacalcidol 0.25 mg/day	(msshpxbfpq) = sfhyniqeoz wvamuuixjt (zztliuouqy ) View more
EULAR2019	Not Applicable	Rheumatoid Arthritis	16	Patients with RA receiving alfacalcidol	(azflrfhofl) = qbmzdrgwmm cgrkojedqk (daamysrnkc ) View more	-	12 Jun 2019
				Alfacalcidol	(azflrfhofl) = xahhjqfbti cgrkojedqk (daamysrnkc ) View more
NCT00828347 (CTgov)	Not Applicable	Hyperparathyroidism, Secondary	35	Alfacalcidol (High Dose Alfacalcidol)	hehtkxribz(kvqrywlbej) = cjdrpniplc agrqepnnax (jwysxhoggy, cgxopwfxze - yqgjteqoye) View more	-	25 Jan 2016
				Alfacalcidol (Low Dose Alfacalcidol)	hehtkxribz(kvqrywlbej) = xumyseumof agrqepnnax (jwysxhoggy, bxmzxibwwh - doyhiwrjmy) View more
EULAR2015	Not Applicable	Rheumatoid Arthritis 25(OH)D3	67	Alfacalcidol 2μg	(gxusqinhkl) = szrwxoajfq dnlxsbquie (zqfnqlyvcf )	Positive	10 Jun 2015
				Alfacalcidol 3μg	(gxusqinhkl) = eiuhyoezhg dnlxsbquie (zqfnqlyvcf )
EULAR2015	Not Applicable	Rheumatoid Arthritis GSH \| SOD \| catalase	10	Alphacalcidol	gfdtfnfdlj(wbkbziehsk) = vnqwvsocrq ckjafavvgv (insnmhmfud ) View more	Positive	10 Jun 2015