UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006027 |
|---|---|
| Receipt number | R000007133 |
| Scientific Title | Examination for the effect of combination therapy using SERM and Eldecalcitol for the patients with osteoporosis |
| Date of disclosure of the study information | 2011/07/25 |
| Last modified on | 2011/07/22 22:26:30 |
* 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
Examination for the effect of combination therapy using SERM and Eldecalcitol for the patients with osteoporosis
Acronym
SERM and Eldecalcitol combination therapy for osteoporosis
Scientific Title
Examination for the effect of combination therapy using SERM and Eldecalcitol for the patients with osteoporosis
Scientific Title:Acronym
SERM and Eldecalcitol combination therapy for osteoporosis
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Obstetrics and Gynecology |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of combination therapy by SERM and Eldecalcitol for patients with osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of bone mineral density
Key secondary outcomes
(1)Number of fracturs occured
(2)Vertebral deformity
(3)Number of falls
(4)Grip power
(5)Changes of bone metabolic markers
(6)Changes of bone quarity makers
(7)Changes of QOL points
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Raloxifene
Interventions/Control_2
Raloxifene + Alfacalcidol(1.0ug/d)
Interventions/Control_3
Raloxifene + Eldecalcitol(0.75ug/d)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Primary osteoposi patients
(2)Patients with informed of consent
Key exclusion criteria
(1)Patients with contraindication for the drugs usend in this study
(2)Patients who do not agree with the participation of this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneaki Ishijima |
Organization
Juntendo University School of Medicine
Division name
Department of Orthopaedics
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muneaki Ishijima |
Organization
Juntendo Hospital
Division name
Department of Orthopaedics
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Medicine for Motor Organ, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine for Motor Organ, Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2011 | Year | 07 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 22 | Day |
Last modified on
| 2011 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007133
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
