UMIN-CTR Clinical Trial

Basic information
Public title	Examination of efficacy and safety treated by denosumab or zoledronate in glucocorticoid-induced osteoporosis
Acronym	Efficacy and safety treated by denosumab orzoledronate in GIO
Scientific Title	Examination of efficacy and safety treated by denosumab or zoledronate in glucocorticoid-induced osteoporosis
Scientific Title:Acronym	Efficacy and safety treated by denosumab orzoledronate in GIO
Region	Japan

Condition
Condition	Glucocorticoid-induced osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the efficacy and safety treated by denosumab or zoledronate in glucocorticoid-induced osteoporosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone mineral density at 60 months after treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	denosumab group
Interventions/Control_2	zoledronate group
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	110 years-old >=
Gender	Female
Key inclusion criteria	1 GIO patients who are more than 20 years old 2 Patients who agree with this study
Key exclusion criteria	1 Patients who have taken denosumab or zoledronate before 2 Patients who are allergic to denosumab or zoledronate 3 Pregnant or breast-feeding patients 4 Renal failure (Ccr is less than 35 mL/min) 5 Dehydrated state 6 Hypocalcemia
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Nakamura
Organization	Shinshu University School of Medicine
Division name	Dept. of Orthopaedic Surgery
Zip code	3908621
Address	Asahi 3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Email	yxn14@aol.jp

Public contact
Name of contact person	1st name Yukio Middle name Last name Nakamura
Organization	Shinshu University School of Medicine
Division name	Dept. of Orthopaedic Surgery
Zip code	3908621
Address	Asahi 3-1-1, Matsumoto 3908621, Japan
TEL	0263372659
Homepage URL
Email	yxn14@aol.jp

Sponsor
Institute	Dept. of Orthopaedic Surgery Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Shinshu University 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)

IRB Contact (For public release)
Organization	Shinshu University School of Medicine
Address	Asahi 3-1-1
Tel	0263372659
Email	yxn14@aol.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 02 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Open public recruiting
Date of protocol fixation	2019 Year 02 Month 05 Day
Date of IRB	2019 Year 02 Month 04 Day
Anticipated trial start date	2019 Year 02 Month 12 Day
Last follow-up date	2024 Year 02 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 12 Day
Last modified on	2019 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040831