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

e-GLORIA trial Protocol Review Committee

Status: Unknown

Conditions: Osteoporosis

Treatments: Drug: Alfacalcidol; Drug: Eldecalcitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01974167

2013/9/9 Ver1.0

UMIN000011700 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Eldecalcitol group

Experimental group

Description:

Eldecalcitol 0.75 microgram once daily orally

Treatment:

Drug: Eldecalcitol

Alfacalcidol group

Active Comparator group

Description:

Alfacalcidol 1 microgram once daily orally

Treatment:

Drug: Alfacalcidol