Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN66814619
• Date of registration: 15/09/2005
• Primary sponsor: Greenpark Healthcare Trust (UK)
• Public title: Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases N/A
• Date of first enrolment: Jan 1 2006
• Target sample size: 300 (150 in each arm)
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN66814619
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

United Kingdom

Contacts

• Name: Madeleine Rooney

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Juvenile Systemic Lupus Erythematosus (JSLE)

Intervention(s)

Randomised to receive either one alpha hydroxycholecalciferol (one-alpha) Or risedronate

Primary Outcome(s)

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

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

15936

Source(s) of Monetary Support

Arthritis Research Campaign (ARC) (UK) (ref:15936)

Secondary Sponsor(s)

N/A