Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
- Registration Number
- NCT01974167
- Lead Sponsor
- e-GLORIA trial Protocol Review Committee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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(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
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(2) Aged between 20 and 85 years (both inclusive) at consent
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(3) Patients who are able to walk without assistance
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(4) Provided consent to participate in the study
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alfacalcidol group Alfacalcidol Alfacalcidol 1 microgram once daily orally Eldecalcitol group Eldecalcitol Eldecalcitol 0.75 microgram once daily orally
- Primary Outcome Measures
Name Time Method Percent change in lumbar spine (L1-4) bone mineral density 12 months after the start of study drug administration Incidence of vertebral fractures 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."
- Secondary Outcome Measures
Name Time Method Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites) 36 months The 3 Major sites are defined as the forearm, humerus, and femur.
Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites) 36 months The 6 Major sites are defined as the femur, lower leg, humerus, forearm, clavicle, and pelvis.
Incidence of non-vertebral fractures (traumatic; All sites) 36 months Incidence of non-vertebral fractures (traumatic; 3 Major sites) 36 months Incidence of non-vertebral fractures (non-traumatic; 3 Major sites） 36 months Incidence of non-vertebral fractures (non-traumatic; 6 Major sites） 36 months Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites) 36 months Incidence of vertebral fractures (clinical vertebral fractures) 36 months Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures 36 months Incidence of new clinical vertebral fractures by severity 36 months SQ method is used for grading of vertebral fractures.
Incidence of FRAX-defined major osteoporotic fractures 36 months The 4 Major sites are defined as clinical fractures of the spine, forearm, hip, and shoulder.
Incidence of non-vertebral fractures (traumatic; 6 Major sites) 36 months Incidence of non-vertebral fractures (non-traumatic; All sites) 36 months Incidence of vertebral fractures (worsening of prevalent vertebral fractures) 36 months Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose 36 months Incidence of non-vertebral fractures (3 Major sites) by bone mineral density 36 months Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures 36 months Incidence of new non-vertebral fractures (all sites) by severity 36 months SQ method is used for grading of vertebral fractures.
Incidence of non-vertebral fractures (all sites) by glucocorticoid dose 36 months Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose 36 months Incidence of non-vertebral fractures (6 Major sites) by bone mineral density 36 months Incidence of vertebral fractures (new or worsening) by number of prevalent fractures 36 months Incidence of clinical vertebral fractures by number of prevalent fractures 36 months Incidence of non-vertebral fractures (all sites) by number of prevalent fractures 36 months Incidence of new non-vertebral fractures (6 Major sites) by severity 36 months Incidence of osteoporotic fractures 36 months 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.
Change in muscle strength (back muscle strength) 36 months after the start of study drug administration (or at the time of withdrawal from the study) Change in muscle strength (grip strength) 36 months after the start of study drug administration (or at the time of withdrawal from the study) Change in height 36 months after the start of study drug administration (or at the time of withdrawal from the study) Incidence of vertebral fractures (new vertebral fractures) 36 months Incidence of clinical vertebral fractures by glucocorticoid dose 36 months Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose 36 months Incidence of clinical vertebral fractures by bone mineral density 36 months Incidence of non-vertebral fractures (all sites) by bone mineral density 36 months Incidence of new vertebral fractures by severity 36 months Semiquantitative (SQ) method is used for grading of vertebral fractures.
Incidence of new non-vertebral fractures (3 Major sites) by severity 36 months SQ method is used for grading of vertebral fractures.
Percent change in TRACP-5b bone metabolism marker 12 months after the start of study drug administration Incidence of vertebral fractures (new or worsening) by bone mineral density 36 months Frequency of falls 36 months Percent change in lumbar spine bone mineral density 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 36 months after the start of study drug administration (or at the time of withdrawal from the study) Percent change in PINP bone metabolism marker 12 months after the start of study drug administration
Trial Locations
- Locations (1)
Nara Hospital Kinki University Faculty of Medicine
🇯🇵Ikoma, Nara, Japan