UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013114 |
|---|---|
| Receipt number | R000015277 |
| Scientific Title | Prospective study for prevention of insufficiency fracture after pelvic irradiation with alendronate and vitamin D |
| Date of disclosure of the study information | 2014/02/19 |
| Last modified on | 2015/02/22 17:18:37 |
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Basic information
Public title
Prospective study for prevention of insufficiency fracture after pelvic irradiation with alendronate and vitamin D
Acronym
Prospective study for prevention of insufficiency fracture with alendronate and vitamin D
Scientific Title
Prospective study for prevention of insufficiency fracture after pelvic irradiation with alendronate and vitamin D
Scientific Title:Acronym
Prospective study for prevention of insufficiency fracture with alendronate and vitamin D
Region
| Japan |
Condition
Condition
Uterine cervical cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of alendronate and vitamin D to prevent insufficiency fracture after definitive radiation therapy for cervical cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of insufficiency fracture after definitive radiation therapy in patients with cervical cancer who are prescribed with alendronate and vitamin D.
Key secondary outcomes
1.The incidence of symptomatic insufficiency fracture after definitive radiation therapy (RT) in patients with cervical cancer who are prescribed with alendronate and vitamin D. 2.The change of bone density after the RT. 3.The change of bone metabolism markers after the RT. 4.The adverese effect of alendronate and vitamin D.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Introduce alendronate and vitamin D at the initiation of radiation therapy for cervical cancer.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)Female whose age is 45 year or more or postmenopause
2)Diagnosed with osteoporosis
3)Candidate for definitive radiation therapy for cervical cancer
4)ECOG Performance status < 2
Key exclusion criteria
1)Patients with esophageal disorder
2)Patients who cannot sit upright for 30 minuites
3)Patients with a history of allergy to bisphosphonate or vitamin D
4)Patients with hypocalcemia who need treatment
5)Patients with severely impaired renal function (serum creatinine >1.5mg/dL)
6)Patients with severely impaired liver or heart function
7)Patients who were treated with antiosteoporotic medication
8)Patients who are planned to undergo intensity modulated radiation therapy
9)Patients who are considered to be inappropriate by the physician
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyawaki Daisuke |
Organization
Kobe University Hospital
Division name
Radiation Oncology
Zip code
Address
7-5-1 Kusunoki-Chou, Chuou-Ku, Kobe, Hyogo
TEL
078-382-6104
miyawaki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyawaki Daisuke |
Organization
Kobe University Hospital
Division name
Radiation Oncology
Zip code
Address
7-5-1 Kusunoki-Chou, Chuou-Ku, Kobe, Hyogo
TEL
078-382-6104
Homepage URL
miyawaki@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Radiation Oncology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Division of Radiation Oncology
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
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
| 2014 | Year | 02 | Month | 19 | 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
| 2014 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | 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
| 2014 | Year | 02 | Month | 09 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015277
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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