UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010413 |
|---|---|
| Receipt number | R000012132 |
| Scientific Title | Open randomized intergroup trial about efficacy and the safety of minodronate raloxifene and eldecalcitol in the drug choice after teriparatide 24 months administration for osteoporosis. |
| Date of disclosure of the study information | 2013/04/03 |
| Last modified on | 2018/03/14 17:33:07 |
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Basic information
Public title
Open randomized intergroup trial about efficacy and the safety of minodronate raloxifene and eldecalcitol in the drug choice after teriparatide 24 months administration for osteoporosis.
Acronym
Controlled trial about the osteoporotic therapeutic drug choice after the teriparatide 24 months administration
Scientific Title
Open randomized intergroup trial about efficacy and the safety of minodronate raloxifene and eldecalcitol in the drug choice after teriparatide 24 months administration for osteoporosis.
Scientific Title:Acronym
Controlled trial about the osteoporotic therapeutic drug choice after the teriparatide 24 months administration
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We determine how bone mineral density and bone biochemical markers change by the difference in choice from minodronate, raloxifene and eldecalcitol after teriparatide 24 months administration and evaluate efficacy and the safety of each drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of bone mineral density in the 24th and the 48th week after medication change.
The change of the bone biochemical markers in the 12th, 24th, 36th and 48th week after medication change.
The occurrence of fracture and adverse event.
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Minodronate administration for 48 weeks. 50mg once /4 week
Interventions/Control_2
Raloxifene administration for 48 weeks. 60mg once /1 day
Interventions/Control_3
Eldecalcitol administration for 48 weeks. 0.75 once /1 day
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Women who had teriparatide administration for 24 months with the criteria for initiating treatment to prevent fragility fractures, which were based on the Japanese Guidelines for the Prevention and Treatment of Osteoporosis (2006 edition).
Accepted informed consent.
Key exclusion criteria
The patients who do not come to the hospital.
The patients who cancele an agreement.
The patients who discontinue osteoporosis medicine.
The patients who have a fracture on the course.
The patients that doctor attending judge cancellation of study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nakatoh |
Organization
Asahi General Hospital
Division name
Orthopedics
Zip code
Address
477 Tomari, Asahimachi, Toyama 939-0741, Japan
TEL
0765-83-1160
nakato38@cosmo21.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Nakatoh |
Organization
Asahi General Hospital
Division name
Orthopedics
Zip code
Address
477 Tomari, Asahimachi, Toyama 939-0741, Japan
TEL
0765-83-1160
Homepage URL
nakato38@cosmo21.net
Sponsor or person
Institute
Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc. Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
あさひ総合病院（富山県） Asahi General Hospital (Toyama pref.)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012132
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| Registered date | File name |
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| Registered date | File name |
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