UMIN-CTR Clinical Trial

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 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
Email	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
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	Asahikawa Medical University Research Ethics Committee
Address	Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido 078-8510, Japan
Tel	0166-68-2297
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030682