Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatic disease despite bisphosphonate over a Year

JRCT ID: jRCT1041190127

Registered date:10/03/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rheumatic disease, Glucocoluticoid-induced osteoporosis
• Date of first enrollment: 03/02/2021
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 12months after that romosozumab 210mg s.c. once monthly for 12months
Arm denosumab, in case denosumab has enough response, based on physician's dicision, denosumab can be continued.
all patients: eldecalcitol 0.75microg ram p.o. once a day (Dose reduced to 0.5microg ram once a d
ay depending on symptoms)

Outcome(s)

• Primary Outcome: Superiority of lumbar bone mineral density increase rate over one year over romosuzumab versus denosumab

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: ASAI SHUJI
• Source(s) of Monetary Support: Nagoya University Hospital Funding for Clinical Development