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

Belfast Health and Social Care Trust, Musgrave Park Hospital0 sites216 target enrollmentFebruary 24, 2006

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Belfast Health and Social Care Trust, Musgrave Park Hospital

•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.