UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008216 |
|---|---|
| Receipt number | R000009674 |
| Scientific Title | Effect of Eldcalcitol/ Raloxifene combination therapy for fall prevention in primary osteoporosis patients: a randomized controlled study. |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2012/06/20 09:21:00 |
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Basic information
Public title
Effect of Eldcalcitol/ Raloxifene combination therapy for fall prevention in primary osteoporosis patients: a randomized controlled study.
Acronym
Effect of Eldcalcitol/ Raloxifene combination therapy for fall prevention
Scientific Title
Effect of Eldcalcitol/ Raloxifene combination therapy for fall prevention in primary osteoporosis patients: a randomized controlled study.
Scientific Title:Acronym
Effect of Eldcalcitol/ Raloxifene combination therapy for fall prevention
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Obstetrics and Gynecology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify and compare the effect of fall prevention of raloxifene plus eldecalcitol versus raloxifene alone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The rate of patients with fall
Key secondary outcomes
Change of lumbar spine bone mineral density
Change of total hip bone mineral density
Change of bone metabolic markers
Fall risk assessment tools
Safty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Raloxifene + eldecalcitol for 48 weeks
Interventions/Control_2
Raloxifene for 48 weeks
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
1.Primary osteoporotic patients
2.Patients who has higher risk of fall
(one-leg standing duration with vision <=15 sec or grip strength of dominant arm <18kg)
3.Patients with informed of consent
Key exclusion criteria
1.Patients who are diagnosed as contraindication of raloxifene treatments
2.Patients who are diagnosed as contraindication of eldecalcitol treatments
3.Treated medicine that may affect bone metabolism
4.Patients with cancer
5.Patients who are inappropriate for this study by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriaki Yamamoto |
Organization
Nigata Rehabilitation Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
761 Kizaki, kita-ku, Nigata-shi, Nigata, Japan
TEL
025-388-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriaki Yamamoto |
Organization
Nigata Rehabilitation Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
761 Kizaki, kita-ku, Nigata-shi, Nigata, Japan
TEL
025-388-2111
Homepage URL
saiko.watanabe@aiko.or.jp
Sponsor or person
Institute
Nigata Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seiro Clinic
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
| 2012 | Year | 06 | Month | 20 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 06 | Month | 20 | Day |
Last modified on
| 2012 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009674
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
