Glucocorticoid-induced osteoporosis
Conditions
Interventions
Eldecalcitol 0.75 micrcogram once daily orally
Alfacalcidol 1 micrcogram once daily orally
Sponsors
e-GLORIA trial Protocol Review Committee (Executive Committee)
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percent change in lumbar spine (L1-4) bone mineral density (at Month 12) - Incidence of vertebral fractures (during 36 months) | — |
Countries
Japan
Contacts
Public ContactAtsushi Mizukami
Mebix, Inc. e-GLORIA Study Group
Outcome results
None listed