Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
e-GLORIA
2 other identifiers
interventional
400
1 country
1
Brief Summary
The purpose of this study is 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedAugust 6, 2014
May 1, 2014
4.2 years
October 28, 2013
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change in lumbar spine (L1-4) bone mineral density
12 months after the start of study drug administration
Incidence of vertebral fractures
A vertebral fracture will be classified as a new fracture (i.e., change from grade 0 to grade 1, 2, or 3) or worsening of a prevalent fracture (i.e., change from grade 1 to grade 2 or 3, or change from grade 2 to grade 3) using a semi-quantitative \[SQ\] method according to the "Vertebral Fracture Assessment Criteria, 2012 revised version."
36 months
Secondary Outcomes (55)
Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)
36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)
36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)
36 months
Incidence of non-vertebral fractures (traumatic; All sites)
36 months
Incidence of non-vertebral fractures (traumatic; 3 Major sites)
36 months
- +50 more secondary outcomes
Study Arms (2)
Eldecalcitol group
EXPERIMENTALEldecalcitol 0.75 microgram once daily orally
Alfacalcidol group
ACTIVE COMPARATORAlfacalcidol 1 microgram once daily orally
Interventions
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, 630-0293, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Toshio Matsumoto
University of Tokushima
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2013
First Posted
November 1, 2013
Study Start
December 1, 2013
Primary Completion
February 1, 2018
Last Updated
August 6, 2014
Record last verified: 2014-05