vertebral fracture vertebral fracture, osteoporosis
Conditions
Interventions
romosozumab(105mg) given on once-monthly, for 6 month.
risedoronate acid(75mg) given on once-monthly, for 6 month.
C557282, D000068296
Romosozumab, Risedronic acid
Sponsors
Tetsunaga Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with vertebral fracture with vertebral body compression on X-ray and with vertebral body signal sntensity change on MRI. 2)Patients with osteoporosis with high risk of oste oporotic fractures. 3)Patients with more than 5 score of NRS(Numerical Rating Scale) at first visiting 4)Patients aged 50 years or older at the time of consect acquisition. 5)Patients who received sufficient explanation before participating in this study, and obtained the patient's free will to consent to the document after sufficient understanding. 6)Inpatients and outpatients
Exclusion criteria
Exclusion criteria: 1)Patients under treatment for osteoporosis at the time of injury. 2)Patients due to high energy trauma. 3)patients with severe kidney disease(eGFR<30). 4)Patients with hypocalcemia 5)Patients who cannot answer the questionnaire due to dementia 6)Patients who need invasive dental treatment 7)Patients who are judged by the principal investigator and the research coordinator to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weeks until NRS (Numerical Rating Scale) decreases to 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Pain score using PDAS, RDQ, PCS and QOL score using EQ-5D 2)Terms of fracture healing by X-ray 3)Change of bone mineral density and bone turnover markers 4)Side effect | — |
Contacts
Public ContactRyo Takatori
Okayama University Hospital
Outcome results
None listed