UMIN-CTR Clinical Trial

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

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011700
Receipt No. R000013676
Scientific Title Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
Date of disclosure of the study information 2013/09/10
Last modified on 2019/04/02

* 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 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Name of lead principal investigator
1st name
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
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
Name of contact person
1st name
Middle name
Last name Mizukami
Organization Mebix, Inc.
Division name e-GLORIA Study Group
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
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
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


Contact us.