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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026725
Receipt No. R000030682
Scientific Title Pelvic insufficiency fracture after radiation therapy:trial of preventing bone fracture with inspection and treatment for osteoporosis.
Date of disclosure of the study information 2017/03/28
Last modified on 2017/03/27

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Basic information
Public title Pelvic insufficiency fracture after radiation therapy:trial of preventing bone fracture with inspection and treatment for osteoporosis.
Acronym Pelvic insufficiency fracture after radiation therapy:trial of preventing bone fracture with inspection and treatment for osteoporosis.
Scientific Title Pelvic insufficiency fracture after radiation therapy:trial of preventing bone fracture with inspection and treatment for osteoporosis.
Scientific Title:Acronym Pelvic insufficiency fracture after radiation therapy:trial of preventing bone fracture with inspection and treatment for osteoporosis.
Region
Japan

Condition
Condition Pelvic insufficiency fracture after radiation therapy
Classification by specialty
Obsterics and gynecology Orthopedics Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy of all pelvic irradiation in the uterine cancer is shown. One of the complications includes pelvic insufficiency fracture after irradiation. The study to prevent pelvic insufficiency fracture after irradiation is not accomplished.This study is intended to reduce the frequency of the pelvic insufficiency fracture after irradiation by inspection and treatmen for osteoporosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence of pelvic insufficiency fracture after irradiation or not.
Five year follow up.
The evaluation depends on CT or MRI when the fracture is doubted clinically.
Key secondary outcomes Transition of bone density and activity of daily living.
Presence of pelvic pain after irradiation.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Inspection of the porosis by X-ray absorptiometry.
If the patient is diagnosed for low bone density or osteoporosis in the Japanese 2015 guidelines for prevention and treatment of osteoporosis, we treat low bone density or osteoporosis.
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The patient of all pelvic irradition for uterine cancer in this hospital.
Key exclusion criteria The patient who has bone metastasis in pelvic.
The patinet who can not take the inspection of porosis.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Tandai
Organization Asahikawa medical university
Division name Department of orthopedic surgery
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-68-2511
Email h0628@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Shibata
Organization Asahikawa medical university
Division name Department of orthopedic surgery
Zip code
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL 0166-68-2511
Homepage URL
Email h0628@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa medical university
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2017 Year 03 Month 28 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 27 Day
Last modified on
2017 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030682

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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