Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases

Not Applicable

Completed

• Conditions: Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Juvenile Systemic Lupus Erythematosus (JSLE); Musculoskeletal Diseases; Other systemic involvement of connective tissue

• Registration Number: ISRCTN66814619
• Lead Sponsor: Greenpark Healthcare Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-15
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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
11. Pregnancy or sexually active subjects unwilling to take appropriate contraceptive measures
12. Any limb-lengthening procedure within 6 months of enrolment
13. Participation in another clinical trial, involving active intervention within 30 days prior to enrolment
14. Creatinine clearance <100 ml/min

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An improvement of 0.5 SDS in bone mineral density (BMD) in the treated group compared to the control

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures