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. - 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.

Daiichi Sankyo Company, Limited0 个研究点目标入组 46 人开始时间: 2017年12月26日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: Daiichi Sankyo Company, Limited
入组人数: 46

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•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

研究者

发起方

Daiichi Sankyo Company, Limited

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