Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000030575
- Lead Sponsor
- Daiichi Sankyo Company, Limited
- Brief Summary
The aim of this exploratory study was to compare the effects of denosumab in combination with csDMARDs and csDMARDs alone on ER inhibition by HRpQCT in patients receiving csDMARDs for the treatment of RA. The results of the study suggested that the additional administration of denosumab may be effective in inhibiting the progression of bone erosion and improving bone erosion. Adverse drug reactions of Denosumab treatment were observed in 26.1%, and hypocalcemia was the most common in 17.4%, it was feasible.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
Not provided
1) Patients complicated of osteoporosis who have not been treated for osteoporosis 2) Patients under treatment with intravenous bisphosphonate formulation and parathyroid hormone formulation 3) Patients under treatment with Denosumab 4) Patients under treatment with Biological disease-modifying anti-rheumatic drug and JAK inhibitor 5) Patients taking adrenal cortex hormone drug in excess of 10 mg / day in terms of prednisolone 6) Patients with a history of hypersensitivity to the components of Desnomab 7) Patients with hypocalcemia 8) Patients who are or may be pregnant 9) Patients currently participating in trials or studies of other medicines or medical devices 10) Patients who are breastfeeding or who want pregnancy during the study period 11) Patients who jugged unsuitable for this study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method