Glucocorticoid-Induced Osteoporosis
Conditions
Interventions
denosumab (60 mg) subcutaneously every 6 months
Alendronate (35 mg) by oral administration once a week
Sponsors
Showa University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patients who meet the glucocorticoid- induced osteoporosis criteria 2) Patient whose age is more than 20 years old
Exclusion criteria
Exclusion criteria: 1) Patients who are considered to be contraindicated for denosumab. 2) Patients who are considered to be contraindicated for alendronate. 3) Cancer patients. 4) Patients who have pretreated with bisphosphonate in recent 6 months. 5) Patients who have pretreated with denosumab in recent 6 months. 6) Patients whose eGFR is less than 35ml/min/1.73m2. 7) Patients whose i-PTH is more than 300ml/min. 8) Patients whose corrected Ca is less than 8.4 mg/dL. 9) Patients who are thought to be inappropriate for this study by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of bone mineral density (BMD) in lumber spine, femoral neck and distal radius at 6, 12 month after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change of bone metabolism markers, rate of continuation, side effect at 6, 12 month after intervention | — |
Countries
Japan
Contacts
Public ContactKen Iseri
Showa University School of Medicine Division of Nephrology, Department of Medicine
Outcome results
None listed