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Alfacalcidol

Generic Name
Alfacalcidol
Brand Names
One-alpha
Drug Type
Small Molecule
Chemical Formula
C27H44O2
CAS Number
41294-56-8
Unique Ingredient Identifier
URQ2517572
Background

Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of vitamin D. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys.

Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

Indication

Alfacalcidol is indicated in adult patients with chronic renal failure for the management of hypocalcemia, secondary hyperparathyroidism, or osteodystrophy.

Alfacalcidol is indicated in the management of nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

Associated Conditions
Hypocalcemia, Hypophosphatemic Rickets, Nutritional Rickets, Osteodystrophy, Osteomalacia, Rickets, Secondary Hyperparathyroidism (SHPT), Hypophosphatemic osteomalacia

A Study on the Prevention and Treatment of GIOP With Eldecalcitol

Phase 4
Not yet recruiting
Conditions
Osteoporosis
Rheumatoid Arthritis
Osteopenia
Interventions
First Posted Date
2024-04-25
Last Posted Date
2024-04-25
Lead Sponsor
Chinese SLE Treatment And Research Group
Target Recruit Count
314
Registration Number
NCT06385093
Locations
🇨🇳

Beijing Luhe hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

🇨🇳

Beijing Shunyi hospital, Beijing, Beijing, China

and more 4 locations

Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients

Phase 4
Not yet recruiting
Conditions
Sarcopenia
Interventions
First Posted Date
2024-02-22
Last Posted Date
2024-02-22
Lead Sponsor
Yonsei University
Target Recruit Count
340
Registration Number
NCT06272227
Locations
🇰🇷

Division of Endocrinology, Department of internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea, Republic of

Using Vitamin D to Reduce Oral Mucosal Inflammation in Chemotherapy Patients With Oral Squamous Cell Carcinoma

Phase 2
Recruiting
Conditions
Oral Mucositis
Oral Squamous Cell Carcinoma
Interventions
First Posted Date
2023-08-29
Last Posted Date
2023-08-29
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
412
Registration Number
NCT06016400
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, China

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

Phase 3
Completed
Conditions
Pelvic Organ Prolapse
Interventions
First Posted Date
2022-08-17
Last Posted Date
2022-08-17
Lead Sponsor
Universitas Padjadjaran
Target Recruit Count
48
Registration Number
NCT05505253
Locations
🇮🇩

Universitas Padjadjaran, Bandung, West Java, Indonesia

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

Not Applicable
Completed
Conditions
End Stage Renal Disease
Interventions
First Posted Date
2021-07-19
Last Posted Date
2024-01-25
Lead Sponsor
Rajavithi Hospital
Target Recruit Count
60
Registration Number
NCT04967469
Locations
🇹🇭

Rajavithi Hospital, Bangkok, Thailand

Role of Alphacalcidol Supplement to Reduce Pain and COMP in Geriatric Knee Osteoarthritis Patients

Phase 3
Completed
Conditions
Aged
Osteoarthritis, Knee
Interventions
First Posted Date
2020-05-28
Last Posted Date
2020-05-28
Lead Sponsor
Syarif Hidayatullah State Islamic University Jakarta
Target Recruit Count
146
Registration Number
NCT04405960
Locations
🇮🇩

Public Health Service Clinic Reni Jaya, South Tangerang, Banten, Indonesia

Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

Phase 4
Completed
Conditions
Cardiac Valve Replacement Complication
Interventions
First Posted Date
2019-09-11
Last Posted Date
2019-09-11
Lead Sponsor
Cairo University
Target Recruit Count
86
Registration Number
NCT04085770
Locations
🇪🇬

El-Demerdash Cardiac Academy Hospital, Ain Shams University, Cairo, Egypt

Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly

Phase 4
Conditions
Elderly Infection
Frail Elderly Syndrome
Interventions
First Posted Date
2017-09-26
Last Posted Date
2017-09-26
Lead Sponsor
Indonesia University
Target Recruit Count
110
Registration Number
NCT03292744
Locations
🇮🇩

Cipto Mangunkusumo National Hospital, Jakarta, Indonesia

Active Vitamin D and Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy

Phase 4
Completed
Conditions
Minimal Change Disease
Nephrotic Syndrome
Interventions
First Posted Date
2017-07-07
Last Posted Date
2025-01-24
Lead Sponsor
University of Aarhus
Target Recruit Count
71
Registration Number
NCT03210688
Locations
🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Regional Hospital Viborg, Viborg, Denmark

Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan

Phase 4
Completed
Conditions
Type 2 Diabetic Nephropathy
Interventions
First Posted Date
2017-05-10
Last Posted Date
2019-10-10
Lead Sponsor
The Third Xiangya Hospital of Central South University
Target Recruit Count
60
Registration Number
NCT03147677
Locations
🇨🇳

Hunan Chenzhou NO.1 People's Hospital, Chenzhou, Hunan, China

🇨🇳

The Third Xiangya Hospital of Central South University, Changsha, Hunan, China

🇨🇳

Hunan Yiyang Central Hospital, Yiyang, Hunan, China

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