To prevent and treat osteoporosis in children with rhuematic diseases taking steroids
- Conditions
- Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) VasculitisTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2005-003129-23-GB
- Lead Sponsor
- Belfast Health and Social Care Trust, Musgrave Park Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 216
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Main objective :<br> Does Risedronate or One –Alpha hydroxycholecalciferol (one alpha) protect/treat children and adolescents with rheumatic diseases from developing low bone density when they are treated with corticosteroids?<br> ;<br> Secondary Objective: Secondary objectives :<br> Does Risedronate or one-alpha use in children and adolescents with rheumatic diseases prevent or reduce fragility fractures?<br> ;<br> Primary end point(s): Change in bone mineral density, as measured by DEXA, at one year<br> New Fractures during trial period<br> ;Timepoint(s) of evaluation of this end point: Endpoint will be measured following completion of all subjects
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Fracture rate;Timepoint(s) of evaluation of this end point: Endpoint will be measured following completion of all subjects