|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-UMIN000013659 |
|
Date of registration:
|
08/04/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of a human anti-RANKL antibody (Denosumab) on prevention of steroid-induced osteoporosis in patients with autoimmune hepatitis (AIH)
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
2014/04/08 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Complete: follow-up continuing |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015931 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not applicable
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Kenichi Ikejima |
|
Address:
|
2-1-1, Hongo, Bunkyo-ku,Tokyo
Japan |
|
Telephone:
|
03-3813-3111 |
|
Email:
|
ikejima@juntendo.ac.jp |
|
Affiliation:
|
Juntendo University School of Medicine Department of Gastroenterology |
|
|
Name:
|
Reiko Yaginuma |
|
Address:
|
2-1-1, Hongo, Bunkyo-ku, Tokyo
Japan |
|
Telephone:
|
03-3813-3111 |
|
Email:
|
yagirei@juntendo.ac.jp |
|
Affiliation:
|
Juntendo University School of Medicine Department of Gastroenterology |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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)
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Biopsy-proven AIH patients who are planned or undergoing oral steroid therapy for more than 3 months
|
|
Intervention(s)
|
<Test A; Randomization test: 1)2)> 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 activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately.
<Test A; Randomization test: 1)2)> 2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.
<Test B; newly intervention> 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.
|
|
Primary Outcome(s)
|
|
Percent changes of bone mineral density (BMD) in 6 months and 12months
|
|
Secondary Outcome(s)
|
|
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
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|