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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011461
Receipt No. R000013241
Scientific Title An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Date of disclosure of the study information 2013/08/12
Last modified on 2018/02/14

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Basic information
Public title An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Acronym OSRANKLE-SIO study
Scientific Title An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Scientific Title:Acronym OSRANKLE-SIO study
Region
Japan

Condition
Condition steroid induced osteoporosis
Classification by specialty
Endocrinology and Metabolism Neurology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the the efficacy and safety of anti-RANKL monoclonal antibody (Denosumab) for steroid induced osteoporosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in bone mineral density of lumber spine
In case of spinal bone osteo-sclerosis or spinal bone fracture, femoral neck or distal 2th finger will be substituted
Incidence rate of pathological bone fracture
Fracture was validated by x-ray and/or MRI scan
Key secondary outcomes Change in bone metabolism markers NTX(serum , urine), bone-type alkaline phosphatase, Magnesium, Calcium, phosphorus, intact PTH, calcitonin
Correlation between bone mineral density and activated vitamin D blood concentration levels
Numerical rating score will be measured for pain

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients will be subcutaneous injected subcutaneously with 60 mg of denosumab every 6 months for 12 months.
All subjects will be treated with daily pills containing calcium, naive Vitamin D, with magnesium supplementation. Activated form of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
Interventions/Control_2 Discontinue the administration of aredoron acid, risedronate, of minodronic acid.
All subjects will be received daily pills containing calcium and naive vitamin D, and magnesium supplementation.
Activated forms of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
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

Not applicable
Gender Male and Female
Key inclusion criteria Plan to use or administration of oral steroid for more than 3 months
With written informed consent
Key exclusion criteria 1)Cancer patients with bone metastasis or expected bone metastasis
2)Hypocalcemia
3)Women who wish to be pregnant or are pregnant, or in lactation
4)Hypersensitivity to the denosumab
5)Cancer patients on cancer treatment or anti-hormonal therapy
6)Dental therapy during this trial
7)Long term use of bisphosphonate and have atypical fracture
8)Severe skin infection
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobutaka Hattori
Organization Juntendo University School of Medicine
Division name Neurology
Zip code
Address 2-1-1 Hongo bunkyo Tokyo 113-8421Japan
TEL 03-3813-3111
Email kazumasa@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Yokoyama
Organization Juntendo University School of Medicine
Division name Neurology
Zip code
Address 2-1-1 Hongo bunkyo Tokyo 113-8421 Japan
TEL 03-3813-3111
Homepage URL
Email kazumasa@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor self
Name of secondary funder(s) None

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 順天堂大学附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 12 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 Completed
Date of protocol fixation
2013 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 07 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 12 Day
Last modified on
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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