UMIN-CTR Clinical Trial

Basic information
Public title	Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Acronym	Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Scientific Title	Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Scientific Title:Acronym	Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Region	Japan

Condition
Condition	Steroid induced osteoporosis
Classification by specialty	Endocrinology and Metabolism Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we examine the noninferiority of denosumab as compared with alendronate, which is regarded as the first-line drug in guidelines for treatment and management of steroid osteoporosis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endopoint is the bone density change after 6 months and 1 year at administration.
Key secondary outcomes	Secondary endpoints are the change of bone metabolism markers during the observation period, morphological vertebral fractures and clinical fractures of the observation period, change of the lumbar TBS and adverse events.

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	the denosumab subcutaneous injection 6 months once treatment group
Interventions/Control_2	the the Alendronate oral weekly treatment 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who satisfy all of the following criteria are included in this study. 1)Patients over 18 years old, male and female unquestioned 2)Guidelines for management and treatment of steroid osteoporosis: Patients with a score of 3 or more with the 2014 algorithm
Key exclusion criteria	Patients falling under any of the following are excluded from this research. 1)Patients who may be pregnant or pregnant, patients who desire pregnancy 2)Patients already taking steroids 3)Patients receiving donosumab or bisphosphonate 4)Patient with a disorder delaying esophageal passage such as esophageal stenosis or achalasia (esophageal relaxation disorder) 5)Patients who are raising their upper body for more than 30 minutes or who can not stand 6)Patients with a history of hypersensitivity to denosumab and alendronate or other bisphosphonates. 7)Patients with hypocalcemia 8)Patients judged inappropriate as subjects by the attending physician
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yosuke Middle name Last name Okada
Organization	University of Occupational and Environmental Health, Japan, School of Medicine
Division name	The First Department of Internal Medicine
Zip code	8078555
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL	093-603-1611
Email	y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Keiichi Middle name Last name Torimoto
Organization	University of Occupational and Environmental Health, Japan, School of Medicine
Division name	The First Department of Internal Medicine
Zip code	8078555
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL	093-603-1611
Homepage URL
Email	torimoto@med.uoeh-u.ac.jp

Sponsor
Institute	The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, School of Medicine
Institute
Department

Funding Source
Organization	The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, 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	University of Occupational and Environmental Health, Japan, School of Medicine
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
Tel	093-603-1611
Email	sunday@pub.uoeh-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	2018 Year 06 Month 23 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	Enrolling by invitation
Date of protocol fixation	2014 Year 07 Month 01 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 23 Day
Last modified on	2019 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037754