Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol

N/AUnknownNCT01974167

e-GLORIA trial Protocol Review Committee400 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Osteoporosis

Interventions

EldecalcitolDRUG

Eldecalcitol 0.75 microgram once daily orally

AlfacalcidolDRUG

Alfacalcidol 1 microgram once daily orally

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 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.

Locations (1)

Nara Hospital Kinki University Faculty of Medicine

Ikoma, Nara, Japan

RECRUITING

Outcomes

Primary Outcomes

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

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."

Time frame: 36 months

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)

The 3 Major sites are defined as the forearm, humerus, and femur.

Time frame: 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.

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

Central Contacts

e-GLORIA trial Office

CONTACT

+81-6229-8937 e-gloria@mebix.co.jp

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Semiquantitative (SQ) method is used for grading of vertebral fractures.

Time frame: 36 months

Incidence of new clinical vertebral fractures by severity

SQ method is used for grading of vertebral fractures.

Time frame: 36 months

Incidence of new non-vertebral fractures (all sites) by severity

SQ method is used for grading of vertebral fractures.

Time frame: 36 months

Incidence of new non-vertebral fractures (3 Major sites) by severity

SQ method is used for grading of vertebral fractures.

Time frame: 36 months

Incidence of new non-vertebral fractures (6 Major sites) by severity

Time frame: 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.

Time frame: 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.

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

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)

Percent change in TRACP-5b bone metabolism marker

Time frame: 6 months after the start of study drug administration

Percent change in TRACP-5b bone metabolism marker

Time frame: 12 months after the start of study drug administration

Percent change in PINP bone metabolism marker

Time frame: 6 months after the start of study drug administration

Percent change in PINP bone metabolism marker

Time frame: 12 months after the start of study drug administration

Frequency of falls

Time frame: 36 months

Change in muscle strength (back muscle strength)

Time frame: 12 months after the start of study drug administration

Change in muscle strength (back muscle strength)

Time frame: 24 months after the start of study drug administration

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)

Change in muscle strength (grip strength)

Time frame: 12 months after the start of study drug administration

Change in muscle strength (grip strength)

Time frame: 24 months after the start of study drug administration

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)

Change in height

Time frame: 12 months after the start of study drug administration

Change in height

Time frame: 24 months after the start of study drug administration

Change in height

Time frame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)