UMIN-CTR Clinical Trial

Public title

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

Acronym

Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH

Scientific Title

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

Scientific Title:Acronym

Efficacy of Denosumab for steroid-induced osteoporosis in patients with AIH

Region

Japan

Condition

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

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of denosumab on prevention for steroid-induced osteoporosis with AIH.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Percent changes of bone mineral density (BMD) in 6 months and 12months

Key secondary outcomes

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

<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.

Interventions/Control_2

<Test A; Randomization test: 1)2)>
2) Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D.

Interventions/Control_3

<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.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key 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

Key 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)

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Ikejima

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku,Tokyo

TEL

03-3813-3111

Email

ikejima@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Reiko Yaginuma

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

yagirei@juntendo.ac.jp

Institute

Juntendo University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

04

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2014

Year

03

Month

28

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

04

Month

07

Day

Last modified on

2016

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015931