Osteoporosis
Conditions
Interventions
investigational material(s)
Generic name etc : Romosozumab
INN of investigational material : Romosozumab
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :
Sponsors
Takeshi Mochizuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Joint rheumatic with high osteoporosis of danger of a bone fracture 2. The age of the time of the agreement merit, more than 20-year-old patient (Only a lady.) 3. The patient who is after menopause since putting it for the lady 4. The patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research
Exclusion criteria
Exclusion criteria: 1. Patient of a hypocalcemia 2. Patient with abnormality of severe blood 3. Patient with severe kidney dysfunction 4. Patient with severe liver dysfunction 5. Patient allergic to natural rubber (latex) 6. The patient who judged additionally that a study person in charge was unsuitable as a subject of research person 7.Patient with the past which is hyperesthesia to an ingredient of experimental drug (ROMOSOZUMABU , DENOSUMABU and ERUDEKARUSHITORU)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The change amount which is the bone density in 12 months (the lumber vertebra) after the treatment starting time and prescription | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy The bone density in the treatment starting time and 3 or 6 months later (the lumber vertebra) The treatment starting time, the bone density in 3 or 6 or 12 months later (hip joint, transcervical and hand), bone metabolism marker (P1NP and TRACP-5b) and disease activity The treatment starting time, the daily life function grade in 12 months later and X-ray check Adverse event | — |
Countries
Japan
Outcome results
None listed