UMIN-CTR Clinical Trial

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