Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Not Applicable
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000036838
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
The percentage change in LS BMD decreased to baseline levels at the postdiscontinuation visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients without informed consent. 2)Patients who are diagnosed with osteoporosis by the time of informed consent in this study. 3)Patients who have received denosumab other than during the phase III study (DESIRABLE). 4)Patients who received bisphosphonates after the date of completion of the DESIRABLE (July 3, 2017). 5)Women who are pregnant or possibly pregnant. 6)Other patients who the investigator considers to be ineligible.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in lumbar spine bone mineral density
- Secondary Outcome Measures
Name Time Method Changes in bone erosion score Changes in bone turnover marker (CTX-I)