Clinical Trials

Numerous clinical trials evaluate alfacalcidol across various metabolic, renal, and musculoskeletal conditions, including secondary hyperparathyroidism, chronic kidney disease, osteoporosis, and diabetic nephropathy. Predominantly comprising Phase 2 through Phase 4 studies, these trials range from completed to terminated or withdrawn status and evaluate key endpoints such as fracture incidence and therapeutic outcomes. Research efforts are supported by a diverse array of sponsors, encompassing both academic medical centers and commercial entities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06385093 UNKNOWN
Rheumatoid Arthritis; Osteoporosis; Osteopenia
Chinese SLE Treatment And Research Group
 2024-06 PHASE4
NCT06272227 UNKNOWN
Sarcopenia
Yonsei University
 2024-02-13 PHASE4
NCT06016400 UNKNOWN
Oral Squamous Cell Carcinoma; Oral Mucositis
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2021-06-14 PHASE2; PHASE3
NCT03210688 COMPLETED
Minimal Change Disease; Nephrotic Syndrome
University of Aarhus
 2018-05-01 PHASE4
NCT04967469 COMPLETED
End Stage Renal Disease
Department of Medical Services Ministry of Public Health of Thailand
 2020-09-01
NCT03183557 UNKNOWN
Osteoporosis
Shinshu University
 2017-10-12 PHASE2
NCT05505253 COMPLETED
Pelvic Organ Prolapse
Universitas Padjadjaran
 2020-11-01 PHASE3
NCT02824718 COMPLETED
Autosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment
Assistance Publique - Hôpitaux de Paris
 2017-06-06 PHASE2
NCT03147677 COMPLETED
Type 2 Diabetic Nephropathy
The Third Xiangya Hospital of Central South University
 2016-07-28 PHASE4
NCT04085770 COMPLETED
Cardiac Valve Replacement Complication
Cairo University
 2017-04-01 PHASE4
NCT01974167 UNKNOWN
Osteoporosis
e-GLORIA trial Protocol Review Committee
 2013-12
NCT03292744 UNKNOWN
Frail Elderly Syndrome; Elderly Infection
Indonesia University
 2017-01-10 PHASE4
NCT04405960 COMPLETED
Osteoarthritis, Knee; Aged
Syarif Hidayatullah State Islamic University Jakarta
 2017-07-01 PHASE3
NCT04085770 Completed
Cardiac Valve Replacement Complication
Cairo University
 2017-04-01 Phase 4
NCT02747381 COMPLETED
Asthma
Cairo University
 2014-08 PHASE4
NCT02895061 COMPLETED
Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis
Phramongkutklao College of Medicine and Hospital
 2015-01
NCT02993302 COMPLETED
Graves Disease
Dr Cipto Mangunkusumo General Hospital
 2014-07 PHASE2
NCT01774812 COMPLETED
Cardiovascular Disease; Sudden Cardiac Death
University of Calgary
 2013-01 PHASE2
NCT01896609 UNKNOWN
Chronic Hepatitis c
MinaPharm Pharmaceuticals
 2013-06 PHASE4
NCT01765010 UNKNOWN
Osteoporosis
Seoul National University Hospital
 2013-01 PHASE4
NCT01752244 UNKNOWN
Obesity
Tehran University of Medical Sciences
 2012-01
NCT01364688 UNKNOWN
Vascular Calcification
Ramathibodi Hospital
 2011-05 PHASE2
NCT02327091 COMPLETED
Muscle Weakness
Indonesia University
 2012-04 PHASE3
NCT02327091 Completed
Muscle Weakness
Indonesia University
 2012-04 Phase 3
NCT00469599 TERMINATED
Secondary Hyperparathyroidism; Chronic Kidney Disease; Vitamin D Deficiency
Zealand University Hospital
 2007-07
NCT01115543 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Mahidol University
 2008-08 PHASE4
NCT00828347 COMPLETED
Secondary Hyperparathyroidism
Kumamoto University
 2008-01
NCT00668330 COMPLETED
Systemic Lupus Erythematosus
Chinese University of Hong Kong
 2007-04 PHASE4
NCT00144456 COMPLETED
Osteoporosis
Chugai Pharmaceutical
 2004-09 PHASE3
NCT01020253 UNKNOWN
Bone Density; Arthroplasty, Replacement, Hip
Yokohama City University Medical Center
 2006-01
NCT00469599 Terminated
Secondary Hyperparathyroidism|Chronic Kidney Disease|Vitamin D Deficiency
Zealand University Hospital
 2007-07 Not Applicable
NCT00168909 COMPLETED
Osteoporosis, Postmenopausal; Osteopenia; Falls
Charite University, Berlin, Germany
 2003-06 PHASE4
NCT00165698 COMPLETED
Postmenopausal Osteoporosis
Eisai Co., Ltd.
 2005-05 PHASE3
NCT00483275 WITHDRAWN
Accidental Falls; Chronic Renal Insufficiency; Aged
Ruhr University of Bochum
 2007-06 PHASE4
NCT00138983 COMPLETED
Rheumatoid Arthritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Polymyositis; Wegener's Granulomatosis
UMC Utrecht
 2000-05 PHASE3

(data from https://clinicaltrials.gov, updated on 2024-04-25)

Check the Alfacalcidol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alfacalcidol acts as a non-selective vitamin D receptor agonist, binding to the receptor to upregulate target gene transcription involved in intestinal calcium and phosphate transport. This activation restores systemic mineral balance and suppresses parathyroid hormone synthesis, thereby preventing bone resorption and improving neuromuscular function in patients with osteoporosis, secondary hyperparathyroidism, and chronic kidney disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.