The effect of Monthly ibandronate iv injected on the low-responders to pre-existing oral BP treatment for the osteoporosis patients - MOVEMENT Study

MOVEMENT Study Protocol Review Committee (executive committee)0 个研究点目标入组 400 人开始时间: 2015年6月5日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients with secondary osteoporosis 2) Lumbar spine bone mineral density (L1-4 or L2-4) T-score<-4.0 L1-4: <0.453 g/cm2 for males and <0.541 g/cm2 for females L2-4: <0.500 g/cm2 for males and <0.534 g/cm2 for females 3) There are findings that may affect the measurement of bone mineral density using DXA. 4) There are at least two fractures in L1-4. 5) Any of the following drugs was administered within eight weeks before enrollment: SERM preparation, sex hormone preparation, adrenal corticosteroid preparation, insulin preparation 6) Any of the following drugs was administered within one year before enrollment: PTH preparation, anti-RANKL antibody preparation, anti-sclerostin antibody preparation, cathepsin K inhibitors, zoledronic acid hydrate, alendronate sodium hydrate, and intravenous fluid preparation 7) Has received intravenous IBN administration 8) Corrected serum Ca level at enrollment is less than 8.4 mg/dL 9) Women who are, are likely to be, or want to become pregnant 10) Those who have a severe heart disease, kidney disease, or liver disease 11) Those who are hypersensitive for BP preparations 12) Those who have active malignant tumor 13) Those who are ineligible for the study judged by the investigator

发起方

MOVEMENT Study Protocol Review Committee (executive committee)