Rheumatic disease, Glucocoluticoid-induced osteoporosis Rheumatic disease, Glucocoluticoid-induced osteoporosis
Conditions
Interventions
arm Romosozumab-denosumab: romosozumab 210mg s.c. once monthly for 12months, after that, denosumab 60mg s.c. once every 6months for 12months
arm Denosumab: denosumab 60mg s.c. once every 6months for 1
Sponsors
ASAI SHUJI
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: In this study, patients who satisfy the following 1) -3) and 4) or 5) are included. 1) When the patient agrees to this study 2) Postmenopausal female rheumatic disease patients who have been treated with steroids for more than 6 months. 3) Rheumatic disease treatment includes steroids and is constant for more than 3 months. 4) Insufficient treatment with bisphosphonate for more than 1 year Femoral or lumbar density T-score -2.5 or less with DEXA Or 5) Those with existing fractures
Exclusion criteria
Exclusion criteria: 1. Previous teriparatide or romosozumab or denosumab use. Strontium use. For other osteoporosis drug s or treatments that affect bone metabolism, a certain wash out period is acceptable. 2. Previous solid org an or bone marrow transplants 3. Previous osteonecrosis of the jaw 4. Hypercalcemia or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range 5. Cardiovascular events within 1 year 6. Patients judg ed to be inappropriate for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority of lumbar bone mineral density increase rate over one year over romosuzumab versus denosumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Rheumatoid arthritis 1) Comparison of 1 year and 2 year disease activity transition (CDAI) in each treatment group and confirmation of treatment status transition 2) Comparison of bone mineral density increase rate of femos (proximal femur and femoral neck) over one year compared with romosozumab denosumab 3) Comparison of changes in joint destruction (delta mTSS) in one year between treatment groups of romosozumab and denosumab, comparison of changes in knee osteophyte area and joint space 4) Rate of bone density increase (lumbar spine, femur) and joint destruction change (delta mTSS), knee osteophyte area, joint row by romosozumab/denosumab, denosumab /romosuzumab, and denosumab / denosumab over the 2 years Comparison of gap change 5) Predictors of joint destruction progression in 1 and 2 years 6) Changes in Ca, P, Cre, bone metabolism marker (PINP TRACP-5b), and changes in disease activity and bone density during the 1 year and 2 year observation periods 7) Frequency of new vulnerable fractures in each treatment group in 1 and 2 years 8) Serious adverse events that occurred during observation Rheumatic disease excluding rheumatoid arthritis 1) Comparison of bone mineral density increase rate of femos (proximal femur and femoral neck) over one year compared with romosozumab denosumab 2) Rate of bone density increase (lumbar spine, femur) by romosozumab/denosumab, denosumab /romosuzumab, and denosumab / denosumab over the 2 years Comparison of gap change 3) Changes in Ca, P, Cre, bone metabolism marker (PINP TRACP-5b) and bone density during the 1 year and 2 year observation periods 4) Frequency of new vulnerable fractures in each treatment group in 1 and 2 years 5) Serious adverse events that occurred during observation | — |
Contacts
Public ContactMochihito Suzuki
Nagoya University Hospital
Outcome results
None listed