Efficacy of romosozumab and post-alendronate therapy on osteogenesis imperfecta

JRCT ID: jRCTs031220726

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: osteogenesis imperfecta with concurrent osteoporosis
• Date of first enrollment: 24/03/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 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 in the morning for 12 months.

Outcome(s)

• Primary Outcome: Rate of change in bone density (lumbar spine) during use of romosozumab from the start of administration to the 12th administration

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.)

Related Information

• Primary Sponsor: Ito Nobuaki