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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008714
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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