UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046435 |
|---|---|
| Receipt number | R000052987 |
| Scientific Title | Study on the relationship between dietary and nutrient intake status and changes in bone mineral density and fracture risk in patients with osteoporosis |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2022/01/13 10:00:49 |
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Basic information
Public title
Study on the relationship between dietary and nutrient intake status and changes in bone mineral density and fracture risk in patients with osteoporosis
Acronym
RD-BOOST study
Scientific Title
Study on the relationship between dietary and nutrient intake status and changes in bone mineral density and fracture risk in patients with osteoporosis
Scientific Title:Acronym
RD-BOOST study
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the dietary and nutritional factors that affect bone mineral density increase and fracture in patients with osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Osteoporotic fracture, bone mineral density increase
Key secondary outcomes
fall, nutritional status, QOL
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed as having osteoporosis
2. Patients who signed informed consent to participate in the study.
Key exclusion criteria
1. Patients who have not been diagnosed as having osteoporosis
2. Patients who declined to participate in the study
3. Patients who are regarded as unsuitable for this study by the investigators.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Kurokawa |
Organization
Saiseikai Suita Hospital
Division name
Orthopedics
Zip code
564-0013
Address
1-2, Kawazono-cho, Suita, Osaka 564-0013, Japan
TEL
06-6382-1521
kurokawa0390d@suita.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Kurokawa |
Organization
Saiseikai Suita Hospital
Division name
Orthopedics
Zip code
564-0013
Address
1-2, Kawazono-cho, Suita, Osaka 564-0013, Japan
TEL
06-6382-1521
Homepage URL
kurokawa0390d@suita.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Suita Hospital, Orthopedics
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Saiseikai Suita Hospital
Address
1-2, Kawazono-cho, Suita, Osaka 564-0013, Japan
Tel
06-6382-1521
sotouchi1631j@suita.saiseikai.or.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
済生会吹田病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 24 | 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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
To determine the effects of dietary and nutritional factors on changes in bone mineral density and fracture risk in patients with osteoporosis through a prospective cohort study.
Management information
Registered date
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052987
