Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis

Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis - Elucidation of the role of Receptor activator of nuclear factor kappa-B (RANK)/RANK ligand (RANKL) signals in the onset and progression of primary biliary cholangitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053038

Enrollment

Registered

2023-12-08

Start date

2023-10-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary biliary cholangitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with PBC

Exclusion criteria

Exclusion criteria: Hypocalcemia (corrected serum calcium level less than 8.4mg/dl) Severe renal dysfunction (eGFR 35 < mL/min/1.73m2) Child-Pugh classification grade B or C Total bilirubin level is 5 mg/dl or more Concomitant with ascites Complicated by poorly controlled hepatic encephalopathy Complicated by uncontrolled malignant tumor Requires dental treatment Taking corticosteroids Patients with a history of hypersensitivity to denosumab

Design outcomes

Primary

Measure	Time frame
Changes in the number of RANK/RANKL/OPG positive cells in the liver from baseline to 12 months after treatment.Patients with osteoporosis are treated with denosumab + UDCA, and patients without osteoporosis are treated with UDCA alone.	—

Countries

Japan

Contacts

Public ContactYoshitaka Arase

Tokai University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

arase@tokai-u.jp0463-93-1121

Outcome results