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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028646
Receipt No. 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

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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
Email 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
Email sadametal@gmail.com

Sponsor
Institute Kameda medical center
Institute
Department

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
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 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
URL(English) https://upload.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


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