UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033122
Receipt No. R000037754
Scientific Title Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Date of disclosure of the study information 2018/06/23
Last modified on 2018/06/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The First Department of Internal Medicine
Zip code
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
Middle name
Last name Keiichi Torimoto
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The First Department of Internal Medicine
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
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
2018 Year 06 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.