UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	Department of Cardiovascular Biology and Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Oucome 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030899