Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatic disease despite bisphosphonate over a Year
- Conditions
- Rheumatic disease, Glucocoluticoid-induced osteoporosis
- Registration Number
- JPRN-jRCT1041190127
- Lead Sponsor
- ASAI SHUJI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method