Prevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS

Belfast Health and Social Care Trust, Musgrave Park Hospital0 个研究点目标入组 216 人开始时间: 2006年2月24日最近更新: 2019年6月30日

试验速览

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•Children and adolescents between the ages of 4 and 18 with a definite diagnosis of JIA, JDM, JSLE and vasculitis who are commencing or are receiving corticosteroids. This is the typical patient group who will receive corticosteroids for these diseases and experience steroid induced osteopenia
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 216
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Children who are commencing steroids but where the duration of steroid treatment is expected to be less than 3 months (i.e. short term) should not be recruited.
•Co-morbid conditions known to be associated with osteopaenia:
•Cystic fibrosis, malabsorption, severe renal disease, severe asthma, cancer, osteogenesis imperfecta, inflammatory bowel disease.
•Have a history of using any bisphosphonate (except for more than a single dose of Risedronate) and/or fluoride (>10 mg per day).
•Have a history of cancer.
•Have untreated rickets within one year prior to enrollment.
•Evidence of clinically significant organic or psychiatric disease on history or physical examination which in the opinion of the investigator would prevent the patient from completing the study.
•Have markedly abnormal pretreatment laboratory findings, except if in the opinion of the investigator, it would not prevent the patient from completing the study.
•Have a history of using anabolic steroids/estrogens/androgens within one year of enrollment.
•Have a documented history of an abnormal or allergic reaction to bisphosphonates.
•Pregnancy or sexually active subjects unwilling to take appropriate contraceptive measures.
•Any limb-lengthening procedure within 6 months of enrollment.

发起方

Belfast Health and Social Care Trust, Musgrave Park Hospital