UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031384
Receipt number R000035832
Scientific Title Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study)
Date of disclosure of the study information 2018/02/20
Last modified on 2022/08/25 13:46:20

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Basic information

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

PBC patients with osteoporosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to compare the efficacy and safety in randomized administration of Denosumab and Zoledronic acid for osteoporosis in patients with primary biliary cholangitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in bone density after 12 months treatment (Lumbar spine and proximal femur)

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Denosumab group
(60 mg Denosumab is administered subcutaneously every 6 month)

Interventions/Control_2

Zoledronic acid group
(5 mg Zoledronic acid is administered intravenously every 12 month)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

89 years-old >

Gender

Male and Female

Key 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

Key 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

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Arase

Organization

Tokai University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

shimokasuya 143, Isehara, Kanagawa, Japan

TEL

0463-93-1121

Email

arase@tokai-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshitaka Arase

Organization

Tokai University Oiso Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

Gakkyo 21-1, Oisotyo, Nakagun, Kanagawa, Japan

TEL

0463-72-3211

Homepage URL


Email

arase@tokai-u.jp


Sponsor or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ministry of Health, Labour and Welfare

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東海大学医学部内科学系消化器内科学
東海大学医学部付属大磯病院消化器内科
東海大学医学部付属東京病院消化器内科
東海大学医学部付属八王子病院消化器内科 
帝京大学医学部内科学講座
福島県立医科大学医学部消化器内科学講座
愛媛大学大学院医学系研究科 消化器・内分泌・代謝内科学
手稲渓仁会病院消化器病センター
帝京大学医学部附属溝口病院第四内科学講座
東京慈恵会医科大学消化器・肝臓内科
国立病院機構長崎医療センター難治性疾患研究センター
福岡大学医学部消化器内科学
九州大学病院免疫膠原病感染症内科
岡山大学大学院医歯薬学総合研究科消化器・肝臓内科学
岩手医科大学内科学講座消化器内科肝臓分野
慶應義塾大学医学部内科学(消化器)
東京女子医科大学消化器内科
関西医科大学内科学第三講座
東京医科大学茨城医療センター消化器内科
新潟大学大学院医歯学総合研究科消化器内科学分野
信州大学医学部附属病院消化器内科 
国立病院機構信州上田医療センター
奈良県立医科大学第三内科
山王メディカルセンター
埼玉医科大学病院消化器内科・肝臓内科
久留米大学医学部内科学講座消化器内科部門
鹿児島大学学術研究院医歯学域医学系 消化器疾患・生活習慣病学       
東京医科大学臨床医学系消化器内科学分野
千葉大学大学院医学研究院消化器内科学
昭和大学藤が丘病院消化器内科
虎の門病院肝臓内科


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 02 Month 16 Day

Date of IRB

2018 Year 02 Month 16 Day

Anticipated trial start date

2018 Year 03 Month 16 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2022 Year 08 Month 14 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 20 Day

Last modified on

2022 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name