TRINITY study
- Conditions
- OsteoporosisD010024
- Registration Number
- JPRN-jRCT1041200081
- Lead Sponsor
- Maruyama Shoichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Patients with osteoporosis on high risk fracture
1.1 a bone mineral density T score of -2.5SD or less and vulnerable fracture 12 months before entry
1.2 a bone mineral density T score of -3.3SD or less at the lumber vertebra
1.3 history of more than two vertebral fractures
1.4 history of grade 3 vertebral fracture by semiquantitative methods
2. Patients on maintenance hemodialysis 3 times a week
3. Patients with more than one-year hemodialysis vintage
4. Patients who are judged stable
5. Older than 20 years and younger than 100 years
6. iPTH < 240 pg/ml at enrollment
7. corrected Ca >=8.4mg/dl at enrollment
8. Patients who are able to write informed consent
1. Patients who have been prescribed romosozumab before
2. Bisphosphonate users within one year
3. Denosumab users within one year
4. Ischemic heart disease, stroke, lower limb amputation within one year
5.Steroid user (10mg/day or more in terms of PSL)
6. Active rheumatoid arthritis
7. Pregnant or breast feeding
8. Patients with severe complication, for instance cancer or severe infections
9. Inapporopriate for this study as judged by attending investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of change in bone mineral density (BMD) at the lumber vertebra by dual-energy X-ray absorptiometry (DXA) after 12 months of treatment relative to baseline between romosozumab intervention group and control group
- Secondary Outcome Measures
Name Time Method