UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009495 |
|---|---|
| Receipt number | R000011155 |
| Scientific Title | Clinical study to evaluate the efficacy of a new vitamin D derivative to the patients with a long history of bisphosphonate treatment |
| Date of disclosure of the study information | 2012/12/06 |
| Last modified on | 2021/06/13 12:21:57 |
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Basic information
Public title
Clinical study to evaluate the efficacy of a new vitamin D derivative to the patients with a long history of bisphosphonate treatment
Acronym
Clinical study to evaluate the efficacy of a new vitamin D derivative to the patients with a long history of bisphosphonate treatment
Scientific Title
Clinical study to evaluate the efficacy of a new vitamin D derivative to the patients with a long history of bisphosphonate treatment
Scientific Title:Acronym
Clinical study to evaluate the efficacy of a new vitamin D derivative to the patients with a long history of bisphosphonate treatment
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the potential complicaitons of eldecalcitol for the treatment of osteoporosis patients with a long history of bisphosphonate administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density and occurrence of fracture.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group treated solely with eldecalcitol
Interventions/Control_2
The group treated in a combination of bisphosphonate and eldecalcitol
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoporosis patients with a long history (longer than 3 years) of bisphophonate administration
Key exclusion criteria
Those who are not physically and mentally sound.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Matsumoto |
Organization
Keio Univesity, School of Medicine
Division name
Dept. of Orthopedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3812
morio@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Horiuchi |
Organization
Keio Univesity School of Medicine
Division name
Dept. of Orthopedic Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3812
Homepage URL
horiuchi@z3.keio.jp
Sponsor or person
Institute
Dept. of Orthopedic Surgery, Keio Univesity, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 12 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011155
| 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 |
