osteogenesis imperfecta with concurrent osteoporosis osteogenesis imperfecta
Conditions
Interventions
210 mg of romosozumab (genetical recombination) is administered subcutaneously once a month for 12 times. After that, 35 mg of alendronate is orally administered once a week with about 180 mL of water
Sponsors
Ito Nobuaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who are diagnosed with osteogenesis imperfecta with type I collagen mutations (COL1A1, COL1A2) based on genetic testing and with concurrent osteoporosis 2. Age: Those who are 20 years of age or older at the time of obtaining consent 3. Gender: Any gender 4. Those who have received a full explanation of the study and have given written consent of their own free will based on a full understanding of the study 5. Those who can make outpatient visits in accordance with the research implementation schedule
Exclusion criteria
Exclusion criteria: 1. Patients participating in other clinical trials at the time consent is obtained 2. Patients who are contraindicated for the use of romosozumab and alendronate - Patients with a history of hypersensitivity to romosozumab - Patients with disorders that slow esophageal transit such as esophageal stricture or achalasia - Patients unable to sit or stand for more than 30 minutes - Patients with a history of hypersensitivity to alendronate or other bisphosphonates - Patients with hypocalcemia 3. Those with serious liver disorder, renal disorder, or cardiovascular disease (JCOG CTCAE version 5.0 Grade 3 will be used as a reference) 4. Those with malignant tumors 5. Those who have a history of serious drug allergy such as anaphylactic shock or a history of serious side effects 6. Those who have participated in a clinical trial and taken an investigational drug within 6 months before obtaining informed consent 7. Those who plan to take osteoporosis drugs such as bisphosphonates and denosumab from the time of obtaining informed consent to the end of the study period 8. Those who have not passed 6 months or more since the last dose of denosumab 9. Those who have not passed one year or more since the last dose of zoledronic acid hydrate 10. Those who are pregnant, may become pregnant, or are breastfeeding 11. Those who are judged unfavorable for participation in this study by the principal investigator or sub investigator (for example, patients who are difficult to perform tests due to dementia, patients who refuse to take blood samples, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of change in bone density (lumbar spine) during use of romosozumab from the start of administration to the 12th administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change in bone mineral density (lumbar spine) during romosozumab use 2. Percentage change in bone mineral density (femur) during romosozumab use 3. Percentage change in bone mineral density (lumbar spine and femur) after transition to alendronic acid 4. Number of fractures and location of fractures during treatment 5. Bone metabolism markers (BAP, TRACP-5b, 25OHD, 1,25OHD) 6. Quality of life surveys (EQ-5D, SF-36) | — |
Contacts
Public ContactNobuaki Ito
The University of Tokyo Hospital
Outcome results
None listed