osteoporosis
Conditions
Interventions
denosumab (60 mg) subcutaneously every 6 months
Alendronate (900 maicrog) by Intravenous administration every 4 weeks
Sponsors
Makita general hospital
Haneda oozora Clinic Adachimotoki jin Clinic Heiwa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hemodialysis patient whose age is not less than 20 years old 2) A written informed consent is obtained. 3) Patients whose T-score is not greater than -2.5 or YAM is less than 70%. Patients with an existing insufficiency whose YAM is less than 80%. 4) Patients who have maintained dialysis therapy for over 6 months 5) Patients whose i-PTH is 60-240.
Exclusion criteria
Exclusion criteria: ) 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 corrected Ca is less than 8.4 mg/dL. 7) Patients with severe liver disease 8) Patients with severe heart disease 9) Patients may be pregnant 10) Patients who have bad oral consitions 11) 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
Makita general hospital Internal medicine
Outcome results
None listed