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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036516
Receipt No. R000041602
Scientific Title Association of osteoporosis with spinal deformity and locomotive syndrome
Date of disclosure of the study information 2019/04/15
Last modified on 2019/04/15

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Basic information
Public title Association of osteoporosis with spinal deformity and locomotive syndrome
Acronym Association of osteoporosis with spinal deformity and locomotive syndrome
Scientific Title Association of osteoporosis with spinal deformity and locomotive syndrome
Scientific Title:Acronym Association of osteoporosis with spinal deformity and locomotive syndrome
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The pharmacotherapy is the first choice for treatment of osteoporosis patients. Comprehensive improvement of locomotive Organs involving locomotive syndrome, are important to prevent fractures caused by falls. The purpose of this study is to clarify the relationship between osteoporosis and Locomo and spinal deformity.
Basic objectives2 Others
Basic objectives -Others Longitudinal study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Basic information: Age, Sex, Height, Weight, Medical history, Oral medicine
Image analysis: Spine alignment, Local lesion, Bone mineral density
Bone metabolic markers: 25OHD, PTH, ucOC, NTX
Questionnaire: 25-question Geriatric Locomotive Function Scale(GLFS-25), Visual analog scale(VAS)
Motor function: Maximum gait speed, 6-minute walk distance(6MD), Timed up and Go(TUG), One leg standing time, grip strength, Locomotive syndrome risk test( Two step test, Stand up test)
Key secondary outcomes

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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Osteoporosis
Community dwelling people
Key exclusion criteria difficulty with independent gait
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Nakamura
Organization Higashi Saitama General Hospital
Division name Saitama Spine Center
Zip code 340-0153
Address 517-5, Yoshino, Satte City, Saitama
TEL 0480-40-1311
Email yunaka.nakamura@gmail.com

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Asahi
Organization Japan University of Health Sciences
Division name School of Health Sciences
Zip code 340-0145
Address 2-555, Hirasuka, Satte City, Saitama
TEL 0480-48-6785
Homepage URL
Email r-asahi@jhsu.ac.jp

Sponsor
Institute Higashi Saitama General Hospital
Institute
Department

Funding Source
Organization Japan University of Health Sciences
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 Japan University of Health Sciences
Address 2-555, Hirasuka, Satte City, Saitama
Tel 0480-48-5806
Email m-sakaue@jhsu.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
2019 Year 04 Month 15 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 04 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 15 Day
Last follow-up date
2024 Year 04 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The objective of the present study was to investigate the relationship between osteoporosis and Locomo, and spinal deformity. In addition, we will clarify cross-sectional and longitudinal characteristics in osteoporosis patients.

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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