Osteoporosis osteoporosis, denosumab, zoledronate, romosozumab
Conditions
Interventions
Denosumab or zoledronate after romosozumab
D000069448, D000077211
denosumab, zoledronate, romosozumab
Sponsors
Takahashi Shinji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients on romosozumab for osteoporosis who are 50 years of age or older and have one of the following criteria at the time of starting romosozumab 1. bone mineral density less than 2.5 SD and more than 1 fragility fracture 2. lumbar spine bone density less than -3.3 SD 3. more than 2 existing vertebral fractures 4. semi-quantitative evaluation method result of existing vertebral fracture is Genant grade 3. 5. judged to be necessary to improve surgical outcomes for osteoporosis 6. more than 7.5 mg of steroids (more than 3 months) and T-score <-2.5 Bone fracture despite treatment with bone resorption inhibitors 8. persistent loss of bone mineral density despite treatment with bone resorption inhibitors Translated with www.DeepL.com/Translator (free version)
Exclusion criteria
Exclusion criteria: 1. patients with severe renal dysfunction (creatinine clearance <35 mL/min) 2. patients with a history of hypersensitivity to denosumab or bisphosphonates 3. patients with dehydration (high fever, severe diarrhea, vomiting, etc.) 4. patients with hypocalcemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (Lumbar spine, Total hip) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone metabolism (P1NP, TRACP-5b) | — |
Contacts
Public ContactShinji Takahashi
Osaka Metropolitan University Hospital
Outcome results
None listed