Clinical trial NCT01974167: Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: glucocorticoid-induced osteoporosis
Lead sponsor: e-GLORIA trial Protocol Review Committee
Sponsor class: INDUSTRY
First posted: 2013-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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) 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.

Primary outcomes:
measure: Percent change in lumbar spine (L1-4) bone mineral density
timeFrame: 12 months after the start of study drug administration
measure: Incidence of vertebral fractures
timeFrame: 36 months
Secondary outcomes:
measure: Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (traumatic; All sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (traumatic; 3 Major sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (traumatic; 6 Major sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (non-traumatic; All sites)
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (non-traumatic; 3 Major sites）
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (non-traumatic; 6 Major sites）
timeFrame: 36 months
measure: Incidence of vertebral fractures (new vertebral fractures)
timeFrame: 36 months
measure: Incidence of vertebral fractures (worsening of prevalent vertebral fractures)
timeFrame: 36 months
measure: Incidence of vertebral fractures (clinical vertebral fractures)
timeFrame: 36 months
measure: Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose
timeFrame: 36 months
measure: Incidence of clinical vertebral fractures by glucocorticoid dose
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (all sites) by glucocorticoid dose
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose
timeFrame: 36 months
measure: Incidence of vertebral fractures (new or worsening) by bone mineral density
timeFrame: 36 months
measure: Incidence of clinical vertebral fractures by bone mineral density
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (all sites) by bone mineral density
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (3 Major sites) by bone mineral density
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (6 Major sites) by bone mineral density
timeFrame: 36 months
measure: Incidence of vertebral fractures (new or worsening) by number of prevalent fractures
timeFrame: 36 months
measure: Incidence of clinical vertebral fractures by number of prevalent fractures
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (all sites) by number of prevalent fractures
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures
timeFrame: 36 months
measure: Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures
timeFrame: 36 months
measure: Incidence of new vertebral fractures by severity
timeFrame: 36 months
measure: Incidence of new clinical vertebral fractures by severity
timeFrame: 36 months
measure: Incidence of new non-vertebral fractures (all sites) by severity
timeFrame: 36 months
measure: Incidence of new non-vertebral fractures (3 Major sites) by severity
timeFrame: 36 months
measure: Incidence of new non-vertebral fractures (6 Major sites) by severity
timeFrame: 36 months
measure: Incidence of osteoporotic fractures
timeFrame: 36 months
measure: Incidence of FRAX-defined major osteoporotic fractures
timeFrame: 36 months
measure: Percent change in lumbar spine bone mineral density
timeFrame: 6 months after the start of study drug administration
measure: Percent change in lumbar spine bone mineral density
timeFrame: 24 months after the start of study drug administration
measure: Percent change in lumbar spine bone mineral density
timeFrame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
measure: Change in proximal femur (total-hip) bone mineral density
timeFrame: 6 months after the start of study drug administration
measure: Change in proximal femur (total-hip) bone mineral density
timeFrame: 12 months after the start of study drug administration
measure: Change in proximal femur (total-hip) bone mineral density
timeFrame: 24 months after the start of study drug administration
measure: Change in proximal femur (total-hip) bone mineral density
timeFrame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
measure: Percent change in TRACP-5b bone metabolism marker
timeFrame: 6 months after the start of study drug administration
measure: Percent change in TRACP-5b bone metabolism marker
timeFrame: 12 months after the start of study drug administration
measure: Percent change in PINP bone metabolism marker
timeFrame: 6 months after the start of study drug administration
measure: Percent change in PINP bone metabolism marker
timeFrame: 12 months after the start of study drug administration
measure: Frequency of falls
timeFrame: 36 months
measure: Change in muscle strength (back muscle strength)
timeFrame: 12 months after the start of study drug administration
measure: Change in muscle strength (back muscle strength)
timeFrame: 24 months after the start of study drug administration
measure: Change in muscle strength (back muscle strength)
timeFrame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
measure: Change in muscle strength (grip strength)
timeFrame: 12 months after the start of study drug administration
measure: Change in muscle strength (grip strength)
timeFrame: 24 months after the start of study drug administration
measure: Change in muscle strength (grip strength)
timeFrame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
measure: Change in height
timeFrame: 12 months after the start of study drug administration
measure: Change in height
timeFrame: 24 months after the start of study drug administration
measure: Change in height
timeFrame: 36 months after the start of study drug administration (or at the time of withdrawal from the study)
Other outcomes:
Locations:
city: Ikoma
country: Japan
facility: Nara Hospital Kinki University Faculty of Medicine
state: Nara
Study officials:
affiliation: University of Tokushima
name: Toshio Matsumoto
role: STUDY_CHAIR
References: