Contact information
Type
Scientific
Primary contact
Dr Madeleine Rooney
ORCID ID
Contact details
Dept of Rheumatology
Queen's University of Belfast
Musculoskeletal Education & Research Unit
Musgrave Park Hospital
Stockman's Lane
Belfast
BT9 7JB
United Kingdom
+44 (0)2890902820
m.rooney@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15936
Study information
Scientific title
Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases
Acronym
Study hypothesis
That the bisphosphonate Risedronate will significantly reduce steroid induced osteopaenia in children and adolescents
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Juvenile Systemic Lupus Erythematosus (JSLE)
Intervention
Randomised to receive either one alpha hydroxycholecalciferol (one-alpha) Or risedronate
Intervention type
Drug
Phase
Not Specified
Drug names
One alpha hydroxycholecalciferol, Risedronate
Primary outcome measures
An improvement of 0.5 SDS in bone mineral density (BMD) in the treated group compared to the control
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2006
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Children and adolescents with JIA, JSLE, JDM, commencing steroids or currently treated with steroids between the ages of 4 and 18 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300 (150 in each arm)
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
30/06/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Rheumatology
Belfast
BT9 7JB
United Kingdom
Sponsor information
Organisation
Greenpark Healthcare Trust (UK)
Sponsor details
Musgrave Park Hospital
Stockmans lane
Belfast
BT97JB
United Kingdom
+44 (0)2890902880
katrina.hughes@greenpark.n-i.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (ARC) (UK) (ref:15936)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary