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


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 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


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

Value
https://center6.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