Reduction of Bone Morbidity Using an Oral Bisphosphonate in Fibrous Dysplasia of Bone - PROFIDYS

ZonMw0 个研究点目标入组 156 人开始时间: 2008年7月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Study I: Patients with fibrous dysplasia with painful lesions of intensity above 3 on a visual scale analog from 0 to 10.
•Study II: Patients with fibrous dysplasia of bone with at least one osteolytic lesion and no current bone pain.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•patients yournger than 8 years
•patients with other diseases or receiving treatments likely to affect bone metabolism
•patients with significant upper gastrointestinal disorders
•renal insufficiency (creatinine clearance <25 ml/min)
•liver disease
•in both studies estrogen replacement therapy will be allowed
•women at child bearing age should have a negative pregnancy test and be willing to use a medically acceptable method of contraception

发起方