UMIN-CTR Clinical Trial

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
Email	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
Email	kurokawa0390d@suita.saiseikai.or.jp

Sponsor
Institute	Saiseikai Suita Hospital, Orthopedics
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052987