UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006027
Receipt No. 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

* 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 Obsterics 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
Email

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
Email

Sponsor
Institute Department of Medicine for Motor Organ, Juntendo University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.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


Contact us.