UMIN-CTR Clinical Trial

Basic information
Public title	Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
Acronym	e-GLORIA trial Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
Scientific Title	Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
Scientific Title:Acronym	e-GLORIA trial Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Percent change in lumbar spine (L1-4) bone mineral density (at Month 12) - Incidence of vertebral fractures (during 36 months)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eldecalcitol 0.75 micrcogram once daily orally
Interventions/Control_2	Alfacalcidol 1 micrcogram once daily orally
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication. (i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent (2) Aged between 20 and 85 years (both inclusive) at consent (3) Patients who are able to walk without assistance (4) Provided consent to participate in the study
Key exclusion criteria	(1) BMD (L1-4 or T-Hip) T score < -3.5 (2) Have 3 or more vertebral fractures between L1 and L4. (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures. (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment. (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment. (6) Have received a parathyroid hormone preparation before the start of study treatment. (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody. (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor. (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study. (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism (11) Pregnant woman or woman who desires to become pregnant (12) Have corrected serum calcium >= 10.4 mg/dL or < 8.0 mg/dL at enrollment. (13) Have corrected urinary calcium > 0.4 mg/dL GF at enrollment. (14) Have a past or current history of urinary calculus. (15) Have eGFR < 30 mL/min/1.73 m2 at enrollment. (16) Have severe liver disease such as cirrhosis or severe heart disease such as severe cardiac failure.
Target sample size	400

Research contact person
Last name of lead principal investigator	1st name (1) Toshio (2) Satoshi Middle name Last name (1) Matsumoto (2) Soen
Organization	(1) University of Tokushima (2) Nara Hospital, Kinki University Faculty of Medicine
Division name	(1) Fujii Memorial Institute of Medical Sciences (2) Department of Orthopaedic Surgery and Rheumatology
Zip code	(1)770-0042 (2)630-0293
Address	(1) 3-18-15 Kuramoto-cho, Tokushima , Japan (2) 1248-1 Otoda-cho, Ikoma, Nara , Japan
TEL	088-633-9116
Email	toshio.matsumoto@tokushima-u.ac.jp

Public contact
1st name of contact person	1st name Atsushi Middle name Last name Mizukami
Organization	Mebix, Inc.
Division name	e-GLORIA Study Group
Zip code	105-0001
Address	Toranomon 33 mori building, 3-8-21 Toranomon, Minato-ku, Tokyo 105-0001, Japan
TEL	03-4362-4504
Homepage URL
Email	e-gloria@mebix.co.jp

Sponsor
Institute	e-GLORIA trial Protocol Review Committee (Executive Committee)
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Takahashi Clinic Institutional Review Board
Address	Medical hat 5-1-31, Iwayakitamachi, Nada-Ku, Kobe-Shi, Hyogo, 657-0846, Japan
Tel	078-882-6432
Email	takahashi_chiken@yahoo.co.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	2013 Year 09 Month 10 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	373
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	Terminated
Date of protocol fixation	2013 Year 09 Month 09 Day
Date of IRB	2013 Year 09 Month 29 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 10 Day
Last modified on	2019 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013676