Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)

Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) - Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031384

Enrollment

Registered

2018-02-20

Start date

2018-03-16

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

PBC patients with osteoporosis

Interventions

Denosumab group (60 mg Denosumab is administered subcutaneously every 6 month) Zoledronic acid group (5 mg Zoledronic acid is administered intravenously every 12 month)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with PBC based on PBC clinical practice guideline 2017 edited by the Ministry of Health, Labor and Welfare 2) Postmenopausal women or men aged 20 years or older, 89 years or younger 3) Patients with the bone density of the lumbar spine (L1-L4) or the proximal part of the femur using dual-energy X-ray absorptiometry is less than 70% (T score -2.5) of young adult mean (YAM) 4) Patients with not previously treated or treated with bisphosphonate treatment 5) Patients who can walk freely 6) Patients who received explanation sufficiently for participation in this study, and obtained written informed consent by their own intention

Exclusion criteria

Exclusion criteria: 1) Patients with hypocalcemia (serum calcium level < 8.4 mg / dl) 2) Patients with severe renal dysfunction (eGFR 35 < mL / min / 1.73 m2) 3) Patients with Child-Pugh classification grade B or C 4) Patients with total bilirubin > 5 mg / dl 5) Patients complicated of ascites 6) Patients complicated of poor control of hepatic encephalopathy 7) Patients with uncontrolled malignant tumor 8) Patients needing dental treatment 9) Patients undergoing corticosteroids therapy 10) Patients with a history of hypersensitivity to denosumab, zoledronic acid hydrate or other bisphosphonate 11) Patients who are judged inappropriate by researchers

Design outcomes

Primary

Measure	Time frame
Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)	—

Secondary

Measure	Time frame
Changes in bone density after 6 months treatment (Lumbar spine and proximal femur) Changes in bone metabolism marker (serum TRACP-5b, serum CTx, serum BAP, serum P1NP) Changes in bone mineral metabolism (ALP, Ca, P, intact PTH, 25(OH)D) Changes in liver function (PT%, AST, ALT, GGT, Alb, T-Bil, D-Bil) Changes in renal function (Cr, BUN, eGFR) Incidence of new fractures (vertebral fractures, non-vertebral fractures) Adverse events	—

Measure

Time frame

Changes in bone density after 6 months treatment (Lumbar spine and proximal femur) Changes in bone metabolism marker (serum TRACP-5b, serum CTx, serum BAP, serum P1NP) Changes in bone mineral metabolism (ALP, Ca, P, intact PTH, 25(OH)D) Changes in liver function (PT%, AST, ALT, GGT, Alb, T-Bil, D-Bil) Changes in renal function (Cr, BUN, eGFR) Incidence of new fractures (vertebral fractures, non-vertebral fractures) Adverse events

—

Countries

Japan

Contacts

Public ContactYoshitaka Arase

Tokai University Oiso Hospital Department of Gastroenterology and Hepatology

arase@tokai-u.jp0463-72-3211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026