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
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
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
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
