UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study of the skeletal related events for the patients with bone metastasis
Acronym	Prospective Study of SREs for bone metastasis
Scientific Title	Prospective Study of the skeletal related events for the patients with bone metastasis
Scientific Title:Acronym	Prospective Study of SREs for bone metastasis
Region	Japan

Condition
Condition	Patients with bone metastasis
Classification by specialty	Medicine in general Orthopedics Radiology Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The high-rate incidence of bone metastasis is reported for advanced cancers. Skeletal-related events (SREs) sometimes occurs and the management of the prevention is considered to be important for maintenance of QOL.
Basic objectives2	Others
Basic objectives -Others	Investigation of the relationships between SREs and the bone density/ bone turnover makers.
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of incidence of SREs
Key secondary outcomes	Bone density, Bone turnover markers, Vitamin D

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	With bone metastasis Concent to this study Performance status 1-3
Key exclusion criteria	Cancer with unknown origin
Target sample size	1000

Research contact person
Last name of lead principal investigator	1st name Hisaki Middle name Last name Aiba
Organization	Nagoya City University
Division name	Department of Orthopaedic Surgery
Zip code	467-8601
Address	1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL	052-853-8236
Email	h-aiba@med.nagoya-cu.ac.jp

Public contact
1st name of contact person	1st name Hisaki Middle name Last name Aiba
Organization	Nagoya City University
Division name	Department of Orthopaedic Surgery
Zip code	467-8601
Address	1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL	052-853-8236
Homepage URL
Email	h-aiba@med.nagoya-cu.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Nagoya City University
Institute
Department

Funding Source
Organization	Self funding
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	Clinical Research Management Center, Nagoya City University Hospital
Address	1, Azakawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
Tel	052-851-5511
Email	clinical_research@med.nagoya-cu.ac.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 01 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	2019 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2029 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not otherwise special

Management information
Registered date	2019 Year 04 Month 02 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041450