UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026725 |
|---|---|
| Receipt number | 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 | 2021/03/30 09:12:20 |
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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
| Obstetrics 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 | Susumu |
| Middle name | |
| Last name | Tandai |
Organization
Asahikawa medical university
Division name
Department of orthopedic surgery
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2511
h0628@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shibata |
Organization
Asahikawa medical university
Division name
Department of orthopedic surgery
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
TEL
0166-68-2511
Homepage URL
h0628@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
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
Asahikawa Medical University Research Ethics Committee
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
Tel
0166-68-2297
sho-kenkyu@jimu.asahikawa-med.ac.jp
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030682
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
