glucocorticoid-induced osteoporosis
Conditions
Interventions
Alendronate group: receive alendronate 35mg once a week for 96 weeks
Alendronate + Alfacalcidol group: receive alendronate 35mg once a week + alfacalcidol 1 (0.5) microgram/day for 96 weeks
Sponsors
Society for glucocorticoid-induced osteoporosis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are initially treated with more than 10 mg/day glucocorticoid (prednisolone) for more than 3 months or scheduled to be treated for more than 3 months.
Exclusion criteria
Exclusion criteria: 1)Patient who was not treated for more than 6 months (except, who had symptomatic vertebral fractures). 2)Patient who has serious renal disorder (EGFR: <35ml or Cre: more than 1.5mg/ml). 3)Patient who has a history of renal stone past 5 years. 4)Patient with primary or secondary hyperparathyroidism. 5)Patient with hyperthyroidism or hypothyroidism. 6)Patients who is diagnosed as contraindication of alendronate treatements or Alfacalcidol. 7)Patient who are treated with warfarin. 8)Patient who is inappropriate for this study by physician. 9)Patient who has experiences of receiving bisphosphonate treatment within 6 months at inclusion of the study. 10)Patient who has experiences of receiving drugs having influence on bone remodeling within 6 months at inclusion of the study (Estrogen, Vitamin D, Calcitonin, Raloxifene, Ipriflavone, Vitamin K, Steroid)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Non symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at 0, 6, 12, 24 months. Bone mineral density values, those are measured at the lumbar spine on day 0 and at 6, 12, 24 months. The serum levels of NTX, osteocalcin, 25(OH)vitamin D, growth hotmone, IGF-, those are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment. | — |
Countries
Japan
Contacts
Public ContactIchiro Tatsuno
Chiba University Graduate School of Medicine Department of Clinical Cell Biology
Outcome results
None listed