UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026938
Receipt number R000030899
Scientific Title Effect of osteoporosis therapy with RANKL inhibitor on coronary calcifications
Date of disclosure of the study information 2017/04/11
Last modified on 2019/03/11 10:05:08

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Basic information

Public title

Effect of osteoporosis therapy with RANKL inhibitor on coronary calcifications

Acronym

Effect of osteoporosis therapy with RANKL inhibitor on coronary calcifications

Scientific Title

Effect of osteoporosis therapy with RANKL inhibitor on coronary calcifications

Scientific Title:Acronym

Effect of osteoporosis therapy with RANKL inhibitor on coronary calcifications

Region

Japan


Condition

Condition

coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of RANKL inhibition, by treatment Denosumab, on progression of coronary calcification in prospective study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression of Coronary Artery Calcification(CAC) score

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We performed cardiac computed tomography to evaluate CAC score. One year after administration of denosumab, we measured their CAC score and compared their scores with those of a control group of female patients.

Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

The women patient who has both CAD and osteoporosis and agree to participate in this study

Key exclusion criteria

1. Patients who can not receive coronary CT
2. Patients with hypocalcemia
3. Patients with allergy to denosumab
4. Patients who will receive tooth extraction in a few days
5. Patients with the expected rest of their life less than 1 year
6. Patients with alcohol/drug dependence during the past 3 months
7. Patients without informed consent
8. Pregnant or possibly pregnant females
9. Patients with latex allergy
10. Patients judged inappropriate for this study by phisician
11. Patients without agreement

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tohru
Middle name
Last name Minamino

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Cardiovascular Biology and Medicine

Zip code

9518510

Address

1-754 Asahimachi-Dori, Niigata, Japan

TEL

0252272185

Email

tminamino@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Ozawa

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Cardiovascular Biology and Medicine

Zip code

9518510

Address

1-754 Asahimachi-Dori, Niigata, Japan

TEL

0252272185

Homepage URL


Email

takuya-o@med.niigata-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Japan Research Foundation for Clinical Pharmacology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Niigata University

Address

1-754, Asahimachi-dori, Chuouku, Niigata, Japan

Tel

0252270912

Email

murooka@adm.niigata-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 11 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

11

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

under submission

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

2013 Year 07 Month 24 Day

Date of IRB

2013 Year 08 Month 28 Day

Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 11 Day

Date trial data considered complete

2019 Year 03 Month 11 Day

Date analysis concluded

2019 Year 03 Month 11 Day


Other

Other related information



Management information

Registered date

2017 Year 04 Month 11 Day

Last modified on

2019 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name