UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008714 |
|---|---|
| Receipt number | R000008615 |
| Scientific Title | Prevention of minodronic acid on fracture at adjacent vertebral body following spinal fusion in osteoporotic patients |
| Date of disclosure of the study information | 2012/09/18 |
| Last modified on | 2020/02/27 15:34:18 |
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Basic information
Public title
Prevention of minodronic acid on fracture at adjacent vertebral body following spinal fusion in osteoporotic patients
Acronym
Prevention of minodronic acid on fracture at adjacent vertebral body following spinal fusion in osteoporotic patients
Scientific Title
Prevention of minodronic acid on fracture at adjacent vertebral body following spinal fusion in osteoporotic patients
Scientific Title:Acronym
Prevention of minodronic acid on fracture at adjacent vertebral body following spinal fusion in osteoporotic patients
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is intended that I inspect the usefulness of the Mino Delon acid hydrate for the bone fracture to occur to a backbone fixed (or I form the vertebral body formation, kyphosis) postoperative adjacent vertebral body in the osteoporotic patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New bone fracture of the adjacent vertebral body with X-rays
Key secondary outcomes
Bone density (if possible as for the bone density of the adjacent vertebral body) of the proximal thighbone by the DXA method,
bone metabolism marker(urinary NTX),
visual analog scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The Minodolon acid hydrate administrated group
Interventions/Control_2
The Minodolon acid hydrate non-administrated group
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I decide to meet the following standards in a backbone fixation (or I form the vertebral body formation, a hunchback) art enforcement case 50 years or older.
1) A case to satisfy a version in osteoporotic diagnostic criteria 2000 by the bone metabolism society.
2) The case that enforced the backbone fixation (or I form the vertebral body formation, kyphosis) art due to a vertebral body bone fracture or the sliding symptom.
3) The case that was provided of the agreement.
Key exclusion criteria
1) The impaired patient who delays stricture of the esophagus or the esophagus passage of a empty Shea (esophagus achalasia)
2) The patient who cannot wake up the upper part of the body at the time of remedy more than 30 minutes
3) Patient of the hypocalcemia
4) A pregnant woman or the woman who may be pregnant
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Konishi Hiroaki |
Organization
Rousaibyoin, Nagasaki
Division name
Orthopedics
Zip code
Address
2-12-5, Setogoe, Sasebo-shi, Nagasaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Baba Hideo |
Organization
Nagasaki University Hospital
Division name
Orthopedics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 18 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 17 | Day |
Last modified on
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008615
