UMIN-CTR Clinical Trial

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

Glucocorticoid-induced osteoporosis

Classification by specialty

Endocrinology and Metabolism	Clinical immunology	Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

e-GLORIA trial Protocol Review Committee (Executive Committee)

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

09

Month

10

Day

Last modified on

2019

Year

04

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013676