An international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta - SHC - INFOI

Schriners Hospitals for Children0 个研究点目标入组 15 人开始时间: 2012年9月18日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•Children, male or female 2 weeks to < 12 months of age, at least at 38 weeks gestational age.
•Any child with phenotypic OI type II, III or IV.
•No previous treatment with bisphosphonates.
•Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed. The assessment will be made 2 weeks after the first assessment and the sample must be a urine collection after a 4-hour fast.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Blood oxygen saturation of less than 90% in room air.
•Serum creatinine level greater than 56 µmol/L.
•Any clinically significant clinical laboratory abnormalities at screening.
•Treatment with any investigational drug within the past 30 days.
•Patients who are unlikely to be able to complete the study or comply with the visit schedule.
•Any disease or planned therapy which will interfere with the procedures or data collection of this trial.

发起方

Schriners Hospitals for Children