UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000017630