A study to assess the safety and efficacy of bisphosphonate treatment in childhood femoral avascular necrosis due to Perthes Disease compared to the standard orthopaedic treatment and care.

The Royal Alexandria Hospital for Children0 个研究点目标入组 140 人开始时间: 2010年5月21日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Diagnosis of unilateral Perthes Disease within the preceeding 6 months and with lateral pillar >50% of the contralateral side at the time of enrolment.

•Diagnosis of Avascular Necrosis of the femoral head not due to Perthes Disease.
•Previous treatment of bisphosphonates.
•Current pregnancy or sexually active and not using a medically acceptable form of birth control.
•Untreated rickets within 1 year of enrolment.
•History of clinically significant organic or psychiatric findings on physical examination, which in the opinion of the investigator would prevent the patient from completing the study.
•History of using any of the following medications: regardless of dose, for at least one month, within 3 months of enrolment: Anabolic agents, Calcitriol, Calcitonin, Fluroide (except dental health products), Glucocorticoids (does not include inhaled Glucocorticoids), Growth Hormone, Parathyroid hormone (PTH), Strontium, anticonvulsant medication.
•At screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 upper limit of normal, thyroid-stimulating hormone (TSH) outside of the normal reference range, Vitamin D < 50nmol/l or Glommerula Filtration Rate (GFR) < 60 ml/min as per the Schwartz formula.

发起方

The Royal Alexandria Hospital for Children