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

+ [26]

Target

VDR

Mechanism

VDR agonists(Vitamin D receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal DiseasesUrogenital Diseases

Active Indication

HypocalcemiaOsteomalaciaVitamin D Deficiency+ [4]

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+ [1]

Regulation-

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Structure/Sequence

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

NCT06016400

/ RecruitingPhase 2/3IIT

A Randomized, Double-blind, Single-center Clinical Trial of Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma

Oral squamous cell carcinoma is the most common malignant tumor of the oral and maxillofacial region. Currently, surgery is the main method of comprehensive treatment. TPF (paclitaxel, cisplatin, and fluorouracil) chemotherapy regimen is one of the important methods for the treatment of oral squamous cell carcinoma. Adjuvant chemotherapy before and after surgery can significantly improve the therapeutic effect of oral cancer patients. Oral mucositis (OM) is a common side effect during chemotherapy, which seriously affects the quality of life of chemotherapy patients and may lead to the termination of chemotherapy. Prevention and treatment of oral mucositis is still an urgent clinical problem. Investigators' previous studies have found that vitamin D can significantly inhibit the proliferation, migration, invasion and metastasis of oral squamous cell carcinoma cells, and vitamin D can protect normal oral mucosal tissue by inhibiting pyroptosis caused by platinum-based chemotherapy drugs. Based on the previous basic research, this project intends to conduct a single-center, prospective, clinical randomized controlled study on the clinical efficacy of vitamin D in reducing oral mucosal inflammation in patients with oral squamous cell carcinoma undergoing TPF chemotherapy, in order to provide evidence-based medical evidence for the clinical use of vitamin D in reducing oral mucosal inflammation in patients with oral cancer chemotherapy. The results of this study are expected to serve as guidelines to guide clinical practice.

Start Date14 Jun 2021

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

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

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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1,365

Literatures (Medical) associated with Alfacalcidol

01 Feb 2025·Surgery

Parathyroid hormone–based algorithm reduces complications after total thyroidectomy

Article

Author: Buffet, Camille ; Gaujoux, Sebastien ; Bertocchio, Jean Philippe ; Chereau, Nathalie ; Menegaux, Fabrice ; Ghander, Cecile

BACKGROUNDHypocalcemia after total thyroidectomy is a frequent complication that can be predicted and best managed by the postoperative measurement of parathyroid hormone levels.METHODSThis study included consecutive patients who underwent total thyroidectomy between 2017 and 2022. Hypocalcemia was defined as serum calcium <8.0 mg/dL and hypoparathyroidism as parathyroid hormone <15 pg/mL. After comparing serum calcium levels on postoperative day 1 and intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy in the first period, an algorithm involving routine postoperative oral calcium and alfacalcidol administration in patients with intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy <20 pg/mL was developed and tested during the second period. The rates of symptomatic hypocalcemia, readmission for hypocalcemia, and permanent hypoparathyroidism were compared between the 2 periods.RESULTSIn the first period, 1,965 total thyroidectomies (1,548 women; mean age, 51 years) were performed, including 617 patients (31%) with central neck dissection for thyroid carcinoma. Of 314 patients (16%) who experienced symptomatic hypocalcemia, only 183 (58%) could be predicted using serum calcium levels on postoperative day 1 <8.0 mg/dL. This rate increased to 96% (301 patients) when using intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy and serum calcium levels on postoperative day 1 (P < .001). Intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy alone could predict symptomatic hypocalcemia in 90% (282) of patients. Hypoparathyroidism was permanent in 20 patients (1%), with a greater predictive value of intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy over serum calcium levels on postoperative day 1 (18/20 [90%] vs 8/20 [40%], P < .01). Using the intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy-based algorithm and preventive calcium supplementation in the second period of the study, 1,420 total thyroidectomies (1,106 women; mean age, 50 years) were performed, including 392 (28%) cases with central neck dissection for thyroid carcinoma. Only 2.3% (32) patients developed a symptomatic hypocalcemia compared with 16% during the first period (P < .001). Thirty-eight patients (2.7%) experienced readmission after total thyroidectomy before implementation of the supplementation protocol in our study compared with 2 patients (0.01%) after we began using the protocol (P < .001). There was no significant difference in permanent hypoparathyroidism between the 2 periods (1.3% vs 1%) (P = .8).CONCLUSIONSThe parathyroid hormone-based algorithm determined by intraoperative parathyroid hormone levels 20 minutes after total thyroidectomy and routine preventive administration of oral calcium/calcitriol reduced the risk of symptomatic hypocalcemia and readmission after total thyroidectomy.

01 Jan 2025·Poultry Science

Efficacy of dietary supplementation with 1α-hydroxycholecalciferol on performance, eggshell quality, serum metabolites, jejunal morphology and bone characteristics of laying hens at the late stage of production

Article

Author: Mahdavi, Reza ; Ghazi, Shahab ; Ghaderi Nik, Maryam ; Gholami, Kourosh

The present study evaluated the effects of 1α-hydroxycholecalciferol (1αOHD₃) supplementation on performance, egg quality, gut morphology, serum metabolites, and bone characteristics of Lohman LSL-Lite laying hens. A total of 180 birds (110 weeks of age) were allocated according to a completely randomized design with five treatments. Each treatment had six replicates containing six hens each. The treatments consisted of basal diet with 2000 IU/kg vitamin D₃, basal diet supplemented with 1.5, 3, 4.5, and 6 μg/kg of 1αOHD₃. Results showed that dietary supplementation with 1αOHD₃ increased the egg production (linear P = 0.002 and quadratic P = 0.009) and gross revenue (linear P = 0.042) whilst it decreased the abnormal eggs (linear P = 0.004 and quadratic P = 0.009) in aged laying hens. Similarly, it linearly and quadratically increased the shell thickness and eggshell strength (P < 0.001). Egg mass (linear P = 0.075) showed a tendency to increase with increasing dietary 1αOHD₃ supplementation levels. The egg quality parameters, including Haugh unit, relative weight of albumen, yolk and eggshell were not affected by the treatments (P > 0.05). Furthermore, 1αOHD₃ supplementation increased the serum levels of calcium (linear P = 0.003 and quadratic P = 0.011), albumin (linear P = 0.016 and quadratic P = 0.033), vitamin D (linear and quadratic P < 0.001), alanine aminotransferase activity (linear P = 0.02) whilst the addition of 1αOHD₃ decreased alkaline phosphatase activity (linear P = 0.003 and quadratic P = 0.011), without affecting the serum levels of phosphorus and aspartate aminotransferase activity (P > 0.05) in laying hens. In addition, the linear tendency to increase was observed (linear P = 0.062) in total protein. Dietary supplementation of 1αOHD₃ increased the tibia diameter (linear P = 0.053), tibia calcium (linear P = 0.004 and quadratic P = 0.014) and tibia strength (linear and quadratic P < 0.001). The addition of 1αOHD₃ did not affect the phosphorus and ash of the tibia (P > 0.05). Linear and quadratic responses were found for crypt depth (linear and quadratic P = 0.001) and villus height to crypt depth ratio (linear P = 0.004 and quadratic P = 0.010). The experimental treatments did not affect the jejunal villus height, villus width and villus surface area in aged laying hens (P > 0.05). Our findings suggest that the inclusion of 1αOHD₃ is beneficial, as it enhances egg production, profitability, eggshell thickness, and tibia quality while reducing the incidence of abnormal eggs during the later phase of egg production.

01 Dec 2024·BMJ Case Reports

Idiopathic hypoparathyroidism presenting as fatigue

Article

Author: Kanakatte Sathyanarayan, Soumya ; Gaddehosur Mylaraiah, Ravishankar

Fatigue is a common symptom encountered in clinical practice, often posing a diagnostic challenge due to its myriad underlying causes. A comprehensive clinical history can serve as a valuable guide in such diagnostic dilemmas. A man in his 30s presented with a history of intermittent fatigue. The history of premature cataract surgery prompted an investigation for hypocalcaemia. Subsequent evaluation revealed hypocalcaemia, hyperphosphatemia and low serum parathyroid hormone. Additionally, elevated creatine kinase and lactate dehydrogenase levels were noted. Treatment with calcium and alfacalcidol yielded a favourable response. This case underscores the significance of revisiting clinical history and considering hypocalcaemia as a potential aetiology in cases of unexplained fatigue. It also emphasises the potential for overlooking the diagnosis due to the inconspicuous nature of hypocalcaemic myopathy in idiopathic hypoparathyroidism.

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
Rickets	-	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	(gtfjbsbbnr) = yybeznruts rzgxmxlwxv (gcqsxeyfzm ) View more	Positive	29 May 2021
				Alfacalcidol	(gtfjbsbbnr) = dwuzascffc rzgxmxlwxv (gcqsxeyfzm ) View more
NCT04085770 (Pubmed \| Clin Ther)	Phase 4	-	86	Alfacalcidol 2 μg/d	funpbkzprj(skpajxfgmf): 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)	pxshrylsby(buuluhrpgx) = poslyliunl euwmsxudfd (wvtrtkkrih, oifoclbufg - opahxidlgv) View more	-	20 Feb 2020
				Placebos+PTU (PTU + Placebos)	pxshrylsby(buuluhrpgx) = jenlfuecnw euwmsxudfd (wvtrtkkrih, qatngqhfew - ckogdohqzx) View more
ESPE2019	Not Applicable	Pseudohypoparathyroidism Type 2	-	Alfacalcidol	(nteybotvjv) = ftzgxmodgz ijwlhjbecq (vxkoafzxju ) View more	-	19 Sep 2019
				Calcium supplements	(nteybotvjv) = hjraklpgel ijwlhjbecq (vxkoafzxju ) View more
SP338 (ERA2019)	Not Applicable	Chronic Kidney Diseases PTH \| Klotho	90	Parycalcitol 1 mg/day	(okciunafej) = zljcgzuuuh ekfigzmufi (pwdatmtnxx ) View more	Positive	13 Jun 2019
				Alfacalcidol 0.25 mg/day	(okciunafej) = zveydagsvk ekfigzmufi (pwdatmtnxx ) View more
EULAR2019	Not Applicable	Rheumatoid Arthritis	16	Patients with RA receiving alfacalcidol	(quagesuruf) = opzhrhsupv pazosujplc (wblqrtmvpw ) View more	-	12 Jun 2019
				Alfacalcidol (Healthy controls)	(quagesuruf) = walpolswvb pazosujplc (wblqrtmvpw ) View more
WCO_IOF_ESCEO2018	Not Applicable	Fibromyalgia blood vitamin D level	32	Alfacalcidol 0.5 ug	dspdqxjnfj(sazeisoscf) = jkdtyqlqym sdchazmakl (wmqceeonrf )	Positive	27 Jul 2018
WCO_IOF_ESCEO2016	Not Applicable	Osteoporosis	80	Alfacalcidol	rguxpcyyqb(suoejhukfa) = fmsbfcjtyc rzbksbjwfk (bvumokzxmp ) View more	Positive	17 May 2016
				Plain Vitamin D	rguxpcyyqb(suoejhukfa) = brbbdugnbn rzbksbjwfk (bvumokzxmp ) View more
NCT00828347 (CTgov)	Not Applicable	Hyperparathyroidism, Secondary	35	Alfacalcidol (High Dose Alfacalcidol)	hyoezmtzuz(jydqgahmdj) = zfyvjpmzhc hawmmgeeal (bizmatujkk, pefpunwguo - nuuphtielp) View more	-	25 Jan 2016
				Alfacalcidol (Low Dose Alfacalcidol)	hyoezmtzuz(jydqgahmdj) = atpfbjcavf hawmmgeeal (bizmatujkk, hrumngjkvq - elolvwqugf) View more
EULAR2015	Not Applicable	Rheumatoid Arthritis 25(OH)D3	67	Alfacalcidol 2μg	(dldyprygpa) = rmefgkkmdf uegntoniex (cculrjsiia )	Positive	10 Jun 2015
				Alfacalcidol 3μg	(dldyprygpa) = vnqunbvbwy uegntoniex (cculrjsiia )