TRINITY study

JRCT ID: jRCT1041200081

Registered date:24/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoporosis
• Date of first enrollment: 24/12/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

am A: Romosozumab (210mg) subcutaneously every month for 12 months
am B: Control

Outcome(s)

• Primary Outcome: 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

1. Rate of change in BMD at the proximal femur, lumber vertebra and femoral neck by DXA after 6, 18, and 24 months of treatment relative to baseline between romosozumab intervention group and control group
2. Change in BMD at the proximal femur, lumber vertebra and femoral neck by DXA after 6, 12, 18, and 24 months of treatment relative to baseline between romosozumab intervention group and control group
3. Rate of change and change in bone metabolic markers (P1NP,BAP,TRACP-5b) after 1, 6, and 12 months of treatment relative to baseline between romosozumab intervention group and control group
4. Rate of change and change in volume of thoracic spine and lunber verebra by 3D image analysis of CT under spinal conditions after 12 and 24 months of treatment relative to baseline between romosozumab intervention group and control group
5. Rate of change and change in height of thoracic spine and lunber verebra by 3D image analysis of CT under spinal conditions after 12 and 24 months of treatment relative to baseline between romosozumab intervention group and control group
6. Proportion of patients who do not have new fracture during intervention period between romosozumab intervention group and control group
7. Dose of VitD
8. Change of iPTH, Ca, P, ALP
9. Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Maruyama Shoichi
• Secondary Sponsor: Hamano Takayuki