Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases

Greenpark Healthcare Trust (UK)0 sites300 target enrollmentSeptember 15, 2005

Overview

Phase: 未知
Intervention: Not specified
Conditions: Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Juvenile Systemic Lupus Erythematosus (JSLE)
Sponsor: Greenpark Healthcare Trust (UK)
Enrollment: 300
Status: Completed
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

September 15, 2005

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

Greenpark Healthcare Trust (UK)

•Children and adolescents with JIA, JSLE, JDM, commencing steroids or currently treated with steroids between the ages of 4 and 18 years

•1\. 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
•2\. Children receiving intermittent pulses of intravenous steroids
•3\. Co\-morbid conditions known to be associated with osteopaenia: Cystic fibrosis, malabsorption, severe renal disease, severe asthma, cancer, osteogenesis imperfecta, inflammatory bowel disease
•4\. Have a history of using any bisphosphonate (except for more than a single dose of risedronate) and/or fluoride (\>10 mg per day)
•5\. Have a history of cancer
•6\. Have untreated rickets within one year prior to enrolment
•7\. 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
•8\. Have markedly abnormal pretreatment laboratory findings, except if in the opinion of the investigator, it would not prevent the patient from completing the study
•9\. Have a history of using anabolic steroids/estrogens/androgens within one year of enrolment
•10\. Have a documented history of an abnormal or allergic reaction to bisphosphonates