Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)

Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH) - Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013659

Enrollment

Registered

2014-04-08

Start date

2014-04-08

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

Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months

Interventions

&lt

Test A

Randomization test: 1)2)&gt

In patients pretreated with bisphosphonates

1) Discontinue the administration of aredoron acid, risedronic acid, or minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take ac

2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D. &lt

Test B

newly intervention&gt

In patients who were not pretreated with bisphosphonates

60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months 2)Patients given written consent after being provided with sufficient explanation about participation in this clinical trial

Exclusion criteria

Exclusion criteria: 1)Cancer patients with bone metastasis or expected bone metastasis 2) Hypocalcemia 3) Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have the possibility of atypical fracture 8)severe skin infection 9)severe impaired renal function (Serum creatinine levels: 2.0mg/dl and higher)

Design outcomes

Primary

Measure	Time frame
Percent changes of bone mineral density (BMD) in 6 months and 12months	—

Secondary

Measure	Time frame
1)Percent changes of bone metabolism markers in 6 months and 12 months 2)Correlation between serum activated vitamin D levels and BMD in 6 months and 12 months	—

Countries

Japan

Contacts

Public ContactReiko Yaginuma

Juntendo University School of Medicine Department of Gastroenterology

yagirei@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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