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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015180
Receipt No. R000017630
Scientific Title The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Date of disclosure of the study information 2015/11/01
Last modified on 2021/03/23

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Basic information
Public title The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Acronym The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Scientific Title The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Scientific Title:Acronym The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to assess the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of bone mineral density after 6 months, 12 months, 18 months,and 24 months
Key secondary outcomes The change of bone metabolism marker (BAP and TRACP-5b) after 3 months, 6 months, 12 months, 18 months,and 24 months

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SC denosumab 60mg every 6 months for 2 years
Interventions/Control_2
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients who took gulcocorticoid (the gulcocorticoid dose was not less than 1mg/day and not more than 10mg/day prednisone or equivalent last 6 months) for over 12 months
2.Patients who took bisphosphonate or teriparatide or activated vitamin D for over 12 months
3.Patients who didn't improvement in bone mineral density compared with 6 months ago
4.Patients who scored >3 in the literature "Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and Mineral Research"
Key exclusion criteria Patients with hypocalcemia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Shuzo
Middle name
Last name Yoshida
Organization Osaka Medical College
Division name Department of Internal Medicine (I)
Zip code 569-886
Address Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL +81-72-683-1221
Email in1307@osaka-med.ac.jp

Public contact
Name of contact person
1st name Takaaki
Middle name
Last name ishida
Organization Osaka Medical College
Division name Department of Internal Medicine (I)
Zip code 659-8686
Address Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL +81-72-683-1221
Homepage URL
Email in1342@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization none
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 Osaka Medical College
Address Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
Tel 072-683-1221
Email rinri@osaka-med.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
2015 Year 11 Month 01 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/33624165/
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/33624165/
Number of participants that the trial has enrolled 56
Results Denosumab significantly increased the mean BMD of the lumbar spine and bilateral hip (5.8%, and 1.3%, respectively).
Results date posted
2021 Year 03 Month 23 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics All patients fulfilled the following inclusion criteria: 1) more than 20
years old; 2) received prednisolone (PSL) of more than 1 mg/day for 12 months; 3) prior treatment of osteoporosis
for more than 12 months (bisphosphonates, rhPTH, or active vitamin D 3 ); 4) no increase in T-score at lumbar spine
or total hip compared to more than 6 months ago; 5) score more than 3 for risk factors based on the Japanese Society for
Bone and Mineral Research guideline for GIOP (prior fracture, age, GC dose, and BMD)
Participant flow Patients with rheumatic diseases were recruited from Osaka Medical College hospital during the
period from March 2015 to February 2017.
Adverse events Fragility fractures occurred in three patients during the study period.
Outcome measures Denosumab significantly increased the mean BMD of the lumbar spine and bilateral hip (5.8%, and 1.3%, respectively).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 09 Month 16 Day
Date of IRB
2014 Year 09 Month 01 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 08 Month 31 Day
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2021 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017630

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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