Primary osteoporosis osteoporosis
Conditions
Interventions
Ibandronate sodium hydrate or denosumab is administered to osteoporosis patients after romosozumab administration.
arm Ibandorontae: ibandoronate 100mg once every 1 month for 12 months
arm Denosumab:
D000077557/D000069448
Ibandorontae,Denosumab
Sponsors
Kobayakawa Tomonori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary osteoporosis 2. Patients who used romosozumab for 12 months 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients who are allergic to lomosozumab and ibandronate 2.hypocalcemia 3.Pregnant or breastfeeding women 4.Patients with reflux esophagitis, esophageal achalasia 5.Patients who cannot keep standing or sitting for more than 60 minutes 6.GFR30mL/min/1.73m2 or less, Dialysis patients 7.Patients with upper gastrointestinal disorders such as dysphagia, esophagitis, gastritis, duodenal inflammation, ulcers 8.Patients judg ed to be inappropriate for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density change (lumbar spine,total hip) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Bone density (total hip, femoral neck) at 6 months, 2.Bone turneover markers at 6 months and 12 months 3.Adverse events at 12 months 4.New vertebral fracture,hip fracture at 12 months | — |
Contacts
Public ContactTomonori Kobayakawa
Orthopeadic and Rheumatologic
Outcome results
None listed