Translational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab - OI-AK

niversity of Cologne0 个研究点开始时间: 2012年11月7日最近更新: 2015年11月16日

试验速览

暂无简介。

•Male or female subjects between 5 years and 10 years of age with molecular proven Osteogenesis imperfecta type III/IV (COL1A1/1A2 mutation)
•Subjects must have been treated for a minimum of 2 years with Neridronate prior to study entry
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•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

•Hypocalcemia (<1.03 mmol/l ionisized Calcium)
•Subjects with reduced renal function (estimated GFR (Schwartz formula) <30ml/min/1.73m2)
•Any other abnormal finding such as physical examination or laboratory evaluation, in the opinion of the investigator that is indicative of a disease that would compromise the safety of the patient when getting Denosumab s.c.

发起方

niversity of Cologne