UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003226
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mdaimon@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medcine, The department of Cardiology
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.