Glucocorticoid-induced osteoporosis
Conditions
Interventions
minodronate 50mg once 4weeks + alfacalcidol 1micrcogram once daily orally
alfacalcidol 1micrcogram once daily orally
Sponsors
m-GLORIA research group
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 for 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. 1 Have any existing insufficiency fracture 2 %YAM <80 3 Oral glucocorticoid daily dose >= 5mg 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 prior to the study treatment. (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years prior to the study treatment. (6) Have received a parathyroid hormone preparation or anti-RANKL antibody prior to the study treatment. (7)Have received any of the following drugs that can affect bone metabolism within 8 weeks prior to the study treatment with the (8) Have received cathepsin K inhibitor antibody or an anti-sclerostin prior to the study treatment. (9) Have received any other investigational product for either clinical trial or post marketing trial within four month(120days) prior to the study treatment in the present study. (10) Pregnant females or females who plan to be pregnant (11) Have peptic ulcers (12) Have history of gastrectomy or broad gastrointestinal resection (13)Have diseases that are likely to delay esophageal transit such as esophagus stenosis or achalasia (14) Cannot keep upright or sitting positioning for 30 minutes or more which taking drug. (15)Have history of severe drug allergy of minodronate or alfacalcidol (16)Have corrected serum calcium >= 10.4 mg/dl or < 8.0 mg/dl on the latest laboratory result. (17)Have corrected urinary calcium > 0.4 mg/dl GF at on the latest laboratory result. (18) Have history of urinary calculus or currently having urinary calculus. (19)Have severe hepatic(the latest laboratory result shows AST,ALT2.5time higher than the normal range(or more than 100IU/L)) and renal dysfunction(the latest laboratory result shows eGFR<30mL/min) and cardiovascular disease (20)Judged inappropriate to participate the study by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of vertebral fractures(during 36 months) Percentage change in lumbar spine bone mineral density(at month 36) | — |
Countries
Japan
Contacts
Public ContactNobuyoshi Hatanaka
Linical Co., Ltd Contract Medical Affairs Division
Outcome results
None listed