UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028646 |
|---|---|
| Receipt number | R000032775 |
| Scientific Title | DECOFRAC-KRH (DEvelopment of Checklist for Osteoporotic FRActure Care in Kameda Rehabilitation Hospital; a Controlled Before-and-After Trial |
| Date of disclosure of the study information | 2017/08/14 |
| Last modified on | 2018/04/18 06:16:00 |
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Basic information
Public title
DECOFRAC-KRH (DEvelopment of Checklist for Osteoporotic FRActure Care in Kameda Rehabilitation Hospital; a Controlled Before-and-After Trial
Acronym
DECOFRAC-KRH study
Scientific Title
DECOFRAC-KRH (DEvelopment of Checklist for Osteoporotic FRActure Care in Kameda Rehabilitation Hospital; a Controlled Before-and-After Trial
Scientific Title:Acronym
DECOFRAC-KRH study
Region
| Japan |
Condition
Condition
Osteoporotic fracture
Osteoporosis
Classification by specialty
| Medicine in general | Geriatrics | Orthopedics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We plan to conduct a controlled before-and-after trial to evaluate the effectiveness of the checklist, which we created to provide a better quality of care for osteoporosis.
We plan to conduct an intervention using the checklist for menopausal women over 50 years old with a recent history of fracture, or men over 50 years old with a recent history of fracture, who will be hospitalized at Kameda Rehabilitation Hospital (KRH). We also plan to conduct a review of retrospective cohort, which includes the patients who could have met the study criteria above, during the same period of 2016.
Then, we plan to compare the difference in the proportions of the patients, who received appropriate treatments for osteoporosis between these groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in the proportion of the patients who received "appropriate treatments" for osteoporosis between two groups.
The definition of "appropriate treatments" is as follows.
1) For a patient with a history of major osteoporotic fracture (either hip or vertebral fracture).
Oral bisphosphonate or denosumab in addition to vitamin D supplement . If a patient is not considered to be a good candidate for oral bisphosphonate or denosumab, the doctor in charge has to provide a convincing reason why an alternative treatment is chosen.
2) For a patient without a history of major osteoporotic fracture.
Measurement of bone mineral density using dual-energy X-ray absorptiometry (DXA), and appropriated treatment described above are provided if osteoporosis is diagnosed based on the result of DXA.
Key secondary outcomes
The difference in the proportion of providing a reference letter, which includes a detail of treatment plan about osteoporosis, upon discharge from KRH.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Menopausal women over 50 years old with a recent history of fracture, and men over 50 years old with a recent history of fracture, who were or will be admitted to KRH.
Key exclusion criteria
1) Patients who deny to attend this trial
2) Patients who are hospitalized due to certain diseases (fracture is not a main diagnosis)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuichi Sada |
Organization
Kameda medical center
Division name
Department of General Internal Medicine
Zip code
Address
929, Higashi-cho, Kamogawa, Chiba, Japan
TEL
81-4-7092-2211
sadametal@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Sada |
Organization
Kameda medical center
Division name
Department of General Internal Medicine
Zip code
Address
929, Higashi-cho, Kamogawa, Chiba, Japan
TEL
81-4-7092-2211
Homepage URL
sadametal@gmail.com
Sponsor or person
Institute
Kameda medical center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
亀田リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
a Controlled Before-and-After Trial
Management information
Registered date
| 2017 | Year | 08 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032775
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/02/11 | DECOFRAC2017年度患者入力(H29.11.19UMIN登録用).xlsx |
