Trial record 2 of 112 for:    GLORIA

Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol (e-GLORIA)

This study is not yet open for participant recruitment.
Verified October 2013 by e-GLORIA trial Protocol Review Committee
Sponsor:
Information provided by (Responsible Party):
e-GLORIA trial Protocol Review Committee
ClinicalTrials.gov Identifier:
NCT01974167
First received: October 28, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Osteoporosis
Drug: Eldecalcitol
Drug: Alfacalcidol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by e-GLORIA trial Protocol Review Committee:

Primary Outcome Measures:
  • Percent change in lumbar spine (L1-4) bone mineral density [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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:
  • Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The 6 Major sites are defined as the femur, lower leg, humerus, forearm, clavicle, and pelvis.

  • Incidence of non-vertebral fractures (traumatic; All sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (traumatic; 3 Major sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (traumatic; 6 Major sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (non-traumatic; All sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (non-traumatic; 3 Major sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (non-traumatic; 6 Major sites) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures (new vertebral fractures) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures (worsening of prevalent vertebral fractures) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures (clinical vertebral fractures) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of clinical vertebral fractures by glucocorticoid dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (all sites) by glucocorticoid dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures (new or worsening) by bone mineral density [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of clinical vertebral fractures by bone mineral density [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (all sites) by bone mineral density [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (3 Major sites) by bone mineral density [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (6 Major sites) by bone mineral density [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of vertebral fractures (new or worsening) by number of prevalent fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of clinical vertebral fractures by number of prevalent fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (all sites) by number of prevalent fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of new vertebral fractures by severity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Semiquantitative (SQ) method is used for grading of vertebral fractures.

  • Incidence of new clinical vertebral fractures by severity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    SQ method is used for grading of vertebral fractures.

  • Incidence of new non-vertebral fractures (all sites) by severity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    SQ method is used for grading of vertebral fractures.

  • Incidence of new non-vertebral fractures (3 Major sites) by severity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    SQ method is used for grading of vertebral fractures.

  • Incidence of new non-vertebral fractures (6 Major sites) by severity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Incidence of osteoporotic fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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.

  • Incidence of FRAX-defined major osteoporotic fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The 4 Major sites are defined as clinical fractures of the spine, forearm, hip, and shoulder.

  • Percent change in lumbar spine bone mineral density [ Time Frame: 6 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Percent change in lumbar spine bone mineral density [ Time Frame: 24 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in proximal femur (total-hip) bone mineral density [ Time Frame: 6 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in proximal femur (total-hip) bone mineral density [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in proximal femur (total-hip) bone mineral density [ Time Frame: 24 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in proximal femur (total-hip) bone mineral density [ Time Frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study) ] [ Designated as safety issue: No ]
  • Percent change in TRACP-5b bone metabolism marker [ Time Frame: 6 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Percent change in TRACP-5b bone metabolism marker [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Percent change in PINP bone metabolism marker [ Time Frame: 6 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Percent change in PINP bone metabolism marker [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Frequency of falls [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Change in muscle strength (back muscle strength) [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in muscle strength (back muscle strength) [ Time Frame: 24 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in muscle strength (back muscle strength) [ Time Frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study) ] [ Designated as safety issue: No ]
  • Change in muscle strength (grip strength) [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in muscle strength (grip strength) [ Time Frame: 24 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in muscle strength (grip strength) [ Time Frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study) ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: 12 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: 24 months after the start of study drug administration ] [ Designated as safety issue: No ]
  • Change in height [ Time Frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eldecalcitol group
Eldecalcitol 0.75 microgram once daily orally
Drug: Eldecalcitol
Eldecalcitol 0.75 microgram once daily orally
Active Comparator: Alfacalcidol group
Alfacalcidol 1 microgram once daily orally
Drug: Alfacalcidol
Alfacalcidol 1 microgram once daily orally

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) Outpatients who are able to walk without assistance
  • (4) Provided consent to participate in the study

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.
  • (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01974167

Contacts
Contact: e-GLORIA trial Office +81-6229-8937 gio@mebix.co.jp

Sponsors and Collaborators
e-GLORIA trial Protocol Review Committee
Investigators
Study Chair: Toshio Matsumoto Institute of Health Bioscience, the University of Tokushima Graduate School
  More Information

No publications provided

Responsible Party: e-GLORIA trial Protocol Review Committee
ClinicalTrials.gov Identifier: NCT01974167     History of Changes
Other Study ID Numbers: 2013/9/9 Ver1.0, UMIN000011700
Study First Received: October 28, 2013
Last Updated: October 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by e-GLORIA trial Protocol Review Committee:
glucocorticoid-induced osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Glucocorticoids
Hydroxycholecalciferols
Vitamin D
1-hydroxycholecalciferol
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014