osteoporosis
Conditions
Interventions
romosozumab group
ibandronate sodium hydrate group
Sponsors
Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.All osteoporosis patients over 20 years old 2. Patients who have already received Denosumab (60 mg once every 6 months) for 2 years or more before the start of the study, and have a bone density value of -2.0 SD or more 3.Patients who received written informed consent based on their own free will after receiving sufficient explanation for participation in this study
Exclusion criteria
Exclusion criteria: 1. If you had previously been treated with romosozumab, ibandronate sodium hydrate 2. If you are allergic to romosozumab, ibandronate sodium hydrate 3. Those who have hypocalcemia 4. For pregnant women or women who are nursing 5.Patients with disorders that delay esophageal passage such as esophageal stricture or achalasia 6.Patients who can not keep standing or sitting for more than 60 minutes when taking 7. Those with severe renal dysfunction (eGFR 30 ml / min / less than 1.73 m2) or those receiving dialysis 8.Patients with upper digestive tract disorder such as dysphagia, esophagitis, gastritis, duodenitis, ulcer etc. 9. Other patients who the research director judged inappropriate as a subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density at 12 months of treatment Younger average 80% achieved | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of hypocalcemia Occurrence of other adverse events | — |
Countries
Japan
Contacts
Public ContactYukio Nakamura
Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Outcome results
None listed