Osteoporosise-GLORIANCT01974167
Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
A study testing Eldecalcitol and Alfacalcidol in people with Osteoporosis, run by e-GLORIA trial Protocol Review Committee at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Eldecalcitol and Alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
- 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
Who cannot join
- (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.
Show all 19Show fewer
- (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.
- (17) Have active malignancy or received treatment for malignancy, including adjuvant therapy, within the past 3 years.
- (18) Have a history of hypersensitivity to eldecalcitol, alfacalcidol, or other vitamin D preparations.
- (19) Other persons judged by the investigator (or subinvestigator) to be inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nara Hospital Kinki University Faculty of Medicine
Ikoma, Nara, 630-0293
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- Eldecalcitol, Alfacalcidol
- Keywords
- glucocorticoid-induced osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EldecalcitolDrug
Eldecalcitol 0.75 microgram once daily orally
AlfacalcidolDrug
Alfacalcidol 1 microgram once daily orally
| Study group | Role | What they receive |
|---|---|---|
| Eldecalcitol group | Experimental | Eldecalcitol 0.75 microgram once daily orally Receives: Drug: Eldecalcitol |
| Alfacalcidol group | Active comparator | Alfacalcidol 1 microgram once daily orally Receives: Drug: Alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in lumbar spine (L1-4) bone mineral density
Measured: 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."
Measured: 36 months
Secondary outcomes (55)
Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)
Measured: 36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)
The 3 Major sites are defined as the forearm, humerus, and femur.
Measured: 36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)
The 6 Major sites are defined as the femur, lower leg, humerus, forearm, clavicle, and pelvis.
Measured: 36 months
Incidence of non-vertebral fractures (traumatic; All sites)
Measured: 36 months
Incidence of non-vertebral fractures (traumatic; 3 Major sites)
Measured: 36 months
Incidence of non-vertebral fractures (traumatic; 6 Major sites)
Measured: 36 months
Incidence of non-vertebral fractures (non-traumatic; All sites)
Measured: 36 months
Incidence of non-vertebral fractures (non-traumatic; 3 Major sites）
Measured: 36 months
Incidence of non-vertebral fractures (non-traumatic; 6 Major sites）
Measured: 36 months
Incidence of vertebral fractures (new vertebral fractures)
Measured: 36 months
Incidence of vertebral fractures (worsening of prevalent vertebral fractures)
Measured: 36 months
Incidence of vertebral fractures (clinical vertebral fractures)
Measured: 36 months
Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose
Measured: 36 months
Incidence of clinical vertebral fractures by glucocorticoid dose
Measured: 36 months
Incidence of non-vertebral fractures (all sites) by glucocorticoid dose
Measured: 36 months
Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose
Measured: 36 months
Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose
Measured: 36 months
Incidence of vertebral fractures (new or worsening) by bone mineral density
Measured: 36 months
Incidence of clinical vertebral fractures by bone mineral density
Measured: 36 months
Incidence of non-vertebral fractures (all sites) by bone mineral density
Measured: 36 months
Incidence of non-vertebral fractures (3 Major sites) by bone mineral density
Measured: 36 months
Incidence of non-vertebral fractures (6 Major sites) by bone mineral density
Measured: 36 months
Incidence of vertebral fractures (new or worsening) by number of prevalent fractures
Measured: 36 months
Incidence of clinical vertebral fractures by number of prevalent fractures
Measured: 36 months
Incidence of non-vertebral fractures (all sites) by number of prevalent fractures
Measured: 36 months
Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures
Measured: 36 months
Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures
Measured: 36 months
Incidence of new vertebral fractures by severity
Semiquantitative (SQ) method is used for grading of vertebral fractures.
Measured: 36 months
Incidence of new clinical vertebral fractures by severity
SQ method is used for grading of vertebral fractures.
Measured: 36 months
Incidence of new non-vertebral fractures (all sites) by severity
SQ method is used for grading of vertebral fractures.
Measured: 36 months
Incidence of new non-vertebral fractures (3 Major sites) by severity
SQ method is used for grading of vertebral fractures.
Measured: 36 months
Incidence of new non-vertebral fractures (6 Major sites) by severity
Measured: 36 months
Incidence of osteoporotic fractures
An osteoporotic fracture is defined as a fracture of the following sites: vertebral body, ribs, pelvis, humerus, clavicle, scapula, sternum, proximal femur, other portions of the femur, tibia, fibula, and forearm.
Measured: 36 months
Incidence of FRAX-defined major osteoporotic fractures
The 4 Major sites are defined as clinical fractures of the spine, forearm, hip, and shoulder.
Measured: 36 months
Percent change in lumbar spine bone mineral density
Measured: 6 months after the start of study drug administration
Percent change in lumbar spine bone mineral density
Measured: 24 months after the start of study drug administration
Percent change in lumbar spine bone mineral density
Measured: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Change in proximal femur (total-hip) bone mineral density
Measured: 6 months after the start of study drug administration
Change in proximal femur (total-hip) bone mineral density
Measured: 12 months after the start of study drug administration
Change in proximal femur (total-hip) bone mineral density
Measured: 24 months after the start of study drug administration
Change in proximal femur (total-hip) bone mineral density
Measured: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Percent change in TRACP-5b bone metabolism marker
Measured: 6 months after the start of study drug administration
Percent change in TRACP-5b bone metabolism marker
Measured: 12 months after the start of study drug administration
Percent change in PINP bone metabolism marker
Measured: 6 months after the start of study drug administration
Percent change in PINP bone metabolism marker
Measured: 12 months after the start of study drug administration
Frequency of falls
Measured: 36 months
Change in muscle strength (back muscle strength)
Measured: 12 months after the start of study drug administration
Change in muscle strength (back muscle strength)
Measured: 24 months after the start of study drug administration
Change in muscle strength (back muscle strength)
Measured: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Change in muscle strength (grip strength)
Measured: 12 months after the start of study drug administration
Change in muscle strength (grip strength)
Measured: 24 months after the start of study drug administration
Change in muscle strength (grip strength)
Measured: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Change in height
Measured: 12 months after the start of study drug administration
Change in height
Measured: 24 months after the start of study drug administration
Change in height
Measured: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- e-GLORIA trial Protocol Review Committee
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshio Matsumoto, Study chair, University of Tokushima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974167
- Sponsor's protocol ID
- 2013/9/9 Ver1.0
- Other IDs
- UMIN000011700
- Acronym
- e-GLORIA
- Status last verified
- May 2014
- First submitted
- 28 Oct 2013
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
- ClinicalTrials.gov ID
- NCT01974167
- Acronym / sponsor ID
- e-GLORIA / 2013/9/9 Ver1.0
- Conditions
- Osteoporosis
- Keywords
- glucocorticoid-induced osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- e-GLORIA trial Protocol Review CommitteeIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2018 (estimated)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eldecalcitol group | Experimental | Drug: EldecalcitolEldecalcitol 0.75 microgram once daily orally |
| Alfacalcidol group | Active comparator | Drug: AlfacalcidolAlfacalcidol 1 microgram once daily orally |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
- (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 (19 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EldecalcitolEldecalcitol 0.75 microgram once daily orally | Drug | Eldecalcitol group |
| AlfacalcidolAlfacalcidol 1 microgram once daily orally | Drug | Alfacalcidol group |
Primary outcome
Percent change in lumbar spine (L1-4) bone mineral density
Time frame: 12 months after the start of study drug administration
Incidence of vertebral fractures
Time frame: 36 months
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."
55 secondary outcomes
Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)
Time frame: 36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)
Time frame: 36 months
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)
Time frame: 36 months
Incidence of non-vertebral fractures (traumatic; All sites)
Time frame: 36 months
Incidence of non-vertebral fractures (traumatic; 3 Major sites)
Time frame: 36 months
Incidence of non-vertebral fractures (traumatic; 6 Major sites)
Time frame: 36 months
Incidence of non-vertebral fractures (non-traumatic; All sites)
Time frame: 36 months
Incidence of non-vertebral fractures (non-traumatic; 3 Major sites）
Time frame: 36 months
Incidence of non-vertebral fractures (non-traumatic; 6 Major sites）
Time frame: 36 months
Incidence of vertebral fractures (new vertebral fractures)
Time frame: 36 months
Incidence of vertebral fractures (worsening of prevalent vertebral fractures)
Time frame: 36 months
Incidence of vertebral fractures (clinical vertebral fractures)
Time frame: 36 months
Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose
Time frame: 36 months
Incidence of clinical vertebral fractures by glucocorticoid dose
Time frame: 36 months
Incidence of non-vertebral fractures (all sites) by glucocorticoid dose
Time frame: 36 months
Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose
Time frame: 36 months
Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose
Time frame: 36 months
Incidence of vertebral fractures (new or worsening) by bone mineral density
Time frame: 36 months
Incidence of clinical vertebral fractures by bone mineral density
Time frame: 36 months
Incidence of non-vertebral fractures (all sites) by bone mineral density
Time frame: 36 months
Incidence of non-vertebral fractures (3 Major sites) by bone mineral density
Time frame: 36 months
Incidence of non-vertebral fractures (6 Major sites) by bone mineral density
Time frame: 36 months
Incidence of vertebral fractures (new or worsening) by number of prevalent fractures
Time frame: 36 months
Incidence of clinical vertebral fractures by number of prevalent fractures
Time frame: 36 months
Incidence of non-vertebral fractures (all sites) by number of prevalent fractures
Time frame: 36 months
Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures
Time frame: 36 months
Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures
Time frame: 36 months
Incidence of new vertebral fractures by severity
Time frame: 36 months
Incidence of new clinical vertebral fractures by severity
Time frame: 36 months
Incidence of new non-vertebral fractures (all sites) by severity
Time frame: 36 months
Incidence of new non-vertebral fractures (3 Major sites) by severity
Time frame: 36 months
Incidence of new non-vertebral fractures (6 Major sites) by severity
Time frame: 36 months
Incidence of osteoporotic fractures
Time frame: 36 months
Incidence of FRAX-defined major osteoporotic fractures
Time frame: 36 months
Percent change in lumbar spine bone mineral density
Time frame: 6 months after the start of study drug administration
Percent change in lumbar spine bone mineral density
Time frame: 24 months after the start of study drug administration
Percent change in lumbar spine bone mineral density
Time frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Change in proximal femur (total-hip) bone mineral density
Time frame: 6 months after the start of study drug administration
Change in proximal femur (total-hip) bone mineral density
Time frame: 12 months after the start of study drug administration
Change in proximal femur (total-hip) bone mineral density
Time frame: 24 months after the start of study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshio Matsumoto study chair
University of Tokushima
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eldecalcitol and Alfacalcidol in people with Osteoporosis, run by e-GLORIA trial Protocol Review Committee at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact e-GLORIA trial Office (+81-6229-8937, e-gloria@mebix.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in lumbar spine (L1-4) bone mineral density (time frame: 12 months after the start of study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.