UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Acronym	Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Scientific Title	Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Scientific Title:Acronym	Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although it is reccomended by bisphosphonate against treatment of steroid-induced osteoporosis, there is insufficient case treated by bisphosphonate. We administered denosumab to patients with steroid-induced osteoporosis against insufficient effect by bisphosphonate, and the efficacy of denosumab were prospectively investigated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes in bone mineral density (BMD) and bone turnover markers were investigated at 24 and 52 weeks.
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Steroid induced osteoporosis uncontrolled bisphosphonate
Key exclusion criteria	Can not use denosumab Can not agree this trial
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Kitamura
Organization	Nihon University School of Medicine
Division name	Division of Hematology and Rheumatology, Department of Medicine
Zip code	173-8610
Address	30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	kitamura.noboru@nihon-u.ac.jp

Public contact
Name of contact person	1st name Npbpru Middle name Last name Kitamura
Organization	Nihon University School of Medicine
Division name	Division of Hematology and Rheumatology Department of Medicine
Zip code	173-8610
Address	30-1 Oyaguchi Kamichi Itabashi-ku Tokyo Japan
TEL	03-3972-8111
Homepage URL
Email	kitamura.noboru@nihon-u.ac.jp

Sponsor
Institute	Others
Institute
Department

Funding Source
Organization	Others
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	Nihon University School of Medicine
Address	30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
Tel	03-3972-8111
Email	kitamura.noboru@nihon-u.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 05 Month 26 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	50
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	Main results already published
Date of protocol fixation	2017 Year 11 Month 01 Day
Date of IRB	2017 Year 12 Month 20 Day
Anticipated trial start date	2017 Year 12 Month 20 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No describe

Management information
Registered date	2020 Year 05 Month 26 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046269