UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Title of the study (Brief title)	Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Region	Japan

Condition
Condition	Glucocorticoid-induced osteoporosis
Classification by specialty	Medicine in general Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare with safety and efficacy of denosumab and alendronate on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percent change in bone mineral density of the lumber spine and femoral neck
Key secondary outcomes	Incident vertebral fracture and non-vertebral fracture safety bone makers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	alendronate 35mg/week +alfacalcidol 0.5ug/day. It continues as glucocorticoid-induced osteoporosis treatment.
Interventions/Control_2	denosumab 60mg/6months +alfacalcidol 0.5ug/day. It continues as glucocorticoid-induced osteoporosis treatment.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Guideline on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society (2014) with adaptation patients.
Key exclusion criteria	Medicine associated with the bone metabolism Pregnancy Abnormality of the serum calcium Less than 30ml/min/1.73m2 of the eGFR Severe complications such as liver, heart, renal disease Hypersentivity
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroyuki Morita
Organization	Gifu University Graduate School of Medicine
Division name	General Internal Medicine
Address	1-1 Yanagido, Gifu, Japan
TEL	81-58-230-6632
Email	hmorita@gifu-u.ac.jp

Public contact
Name of contact person	Takahide Ikeda
Organization	Gifu University Graduate School of Medicine
Division name	General Internal Medicine
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6632
Homepage URL
Email	tacahide@nifty.com

Sponsor
Institute	Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Gifu 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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 06 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

Management information
Registered date	2015 Year 11 Month 05 Day
Last modified on	2017 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022700