UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathophysiological study on periarticular osteoporosis in Rheumatoid Arthritis
Title of the study (Brief title)	Periarticular osteoporosis in RA
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the pathophysiology of periarticular osteoporosis in RA, bone and cellular samples are to be retrieved and examined histologically and biologically.
Basic objectives2	Others
Basic objectives -Others	The correlation between disease activity and osteoporosis is to be analyzed.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	bone formation and bone resorption functions of bone marrow cells
Key secondary outcomes	bone mineral density and micro-architecture

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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who undergo total joint arthroplasty and give a full consent to this study, and patients with RA or primary osteoporosis giving a full consent to this study
Key exclusion criteria	Patients who cannot give a full consent to this study including children and cognitively-ill patients
Target sample size	260

Research contact person
Name of lead principal investigator	Takashi Nakamura
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-3652
Email	hiromu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiromu Ito
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	54, Kawahara-cho, Shogoin, Sakyo, Kyoto
TEL	075-751-3652
Homepage URL	http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/
Email	hiromu@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Orthopaedic Surgery, Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 07 Month 30 Day
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	medication, treatment history, laboratory data, urinary data, BMD, MRI, CT, X-ray, DAS28(ESR)

Management information
Registered date	2010 Year 07 Month 29 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004782