UMIN-CTR Clinical Trial

Basic information
Public title	Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis
Acronym	Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis
Scientific Title	Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritis
Scientific Title:Acronym	Evaluation of the Therapeutic Effect of Denosumab on Rheumatoid Arthritis and Osteoporosis
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of denosumab in treating osteoporosis and inhibiting bone erosion in rheumatoid arthritis cases.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of Bone Mineral Density at week 52
Key secondary outcomes	Evaluation of Bone Erosion at week 52

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	Meet the diagnosis of rheumatoid arthritis and osteoporosis
Key exclusion criteria	Use of parathyroid hormones drugs History of bone metabolic disease hypocalcemia
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Mori
Organization	Tohoku University Graduate School of Medicine
Division name	Orthopedic Surgery
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	0227177245
Email	yu-mori@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Mori
Organization	Tohoku University Graduate School of Medicine
Division name	Orthopedic Surgery
Zip code	9808574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	0227177245
Homepage URL
Email	yu-mori@med.tohoku.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine
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	Tohoku University Graduate School of Medicine Ethics Committee
Address	2-1 Seiryo-machi, Aoba-ku, Sendai
Tel	0227178007
Email	med-kenkyo@grp.tohoku.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 10 Month 14 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	Completed
Date of protocol fixation	2020 Year 10 Month 12 Day
Date of IRB	2020 Year 12 Month 24 Day
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N/A

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2021 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048053