UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003226 |
|---|---|
| Receipt number | R000003906 |
| Scientific Title | Effects of risedronate on the progression of aortic valv stenosis in osteoporosis patients |
| Date of disclosure of the study information | 2010/02/22 |
| Last modified on | 2015/02/22 09:13:53 |
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Basic information
Public title
Effects of risedronate on the progression of aortic valv stenosis in osteoporosis patients
Acronym
ROTAS(Risedronate and Osteoporosis Therapy in Aortic valve Stenosis)
Scientific Title
Effects of risedronate on the progression of aortic valv stenosis in osteoporosis patients
Scientific Title:Acronym
ROTAS(Risedronate and Osteoporosis Therapy in Aortic valve Stenosis)
Region
| Japan |
Condition
Condition
Aortic valve stenosis with osteoporosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of risedronate on the progression of aortic valve stenosis and calcification in patients with osteoporosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of aortic valve stenosis assessed by echocardiography
Left ventricular mass
Clinical events or symptom
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with risedronate and alfacalcidol
Interventions/Control_2
Treatment with alfacalcidol
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
1. mild to moderate aortic valve stenosis or calcification on echocardiography without operative indication
2. postmenopausal women
3. patients in whom written informed consent was obtained after a detailed explanation of the study purpose and methods
4. patients who should have medical therapy for osteoporosis based upon 2006 Guideline for the prevention and treatment in patients osteoprosis
Key exclusion criteria
1.rheumatic mitral valve disease
2.patients receiving treatment with oral bisphosphonates
3.congestive heart failure
4.bicuspid aortic valve
5.renal failure(eGFR<30)
6.hepatic dysfunction
7.mild aortic regurgitation, and previous aortic valve surgery
8.patients with hormone recruitment therapy
9.not suitable to this study based upon doctor's judge
10.Abnormalities of the esophagus such a achalasia
11.Known hypersensitivity to any component of this product
12.Hypocalcemia
13.Inability to stand or sit upright for at least 30 minutes after taking the medication
14.patients requiring dental treatment or within 2 month after dental treatment
15.active gastric and duodenal ulcers
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Daimon |
Organization
Juntendo university School of medicine
Division name
The department of cardiology
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
mdaimon@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Daimon |
Organization
Juntendo university School of medicine
Division name
The department of cardiology
Zip code
Address
Bunkyo-ku Hongo2-1-1
TEL
03-3813-3111
Homepage URL
mdaimon@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medcine, The department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medcine, The department of Cardiology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University School of Medcine, the department of orthopedic surgery
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 02 | Month | 22 | 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
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 22 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003906
