Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Juvenile Systemic Lupus Erythematosus (JSLE) Musculoskeletal Diseases Other systemic involvement of connective tissue
Conditions
Interventions
Randomised to receive either one alpha hydroxycholecalciferol (one-alpha) Or risedronate
Sponsors
Greenpark Healthcare Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement of 0.5 SDS in bone mineral density (BMD) in the treated group compared to the control | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed