Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases

ISRCTN	ISRCTN66814619
DOI	https://doi.org/10.1186/ISRCTN66814619
Secondary identifying numbers	15936

Submission date: 22/08/2005
Registration date: 15/09/2005
Last edited: 24/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Madeleine Rooney
Scientific

Dept of Rheumatology
Queen's University of Belfast
Musculoskeletal Education & Research Unit
Musgrave Park Hospital
Stockman's Lane
Belfast
BT9 7JB
United Kingdom

Phone	+44 (0)2890902820
Email	m.rooney@qub.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases
Study objectives	That the bisphosphonate Risedronate will significantly reduce steroid induced osteopaenia in children and adolescents
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	One alpha hydroxycholecalciferol, Risedronate
Primary outcome measure	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 study start date	01/01/2006
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	300 (150 in each arm)
Key inclusion criteria	Children and adolescents with JIA, JSLE, JDM, commencing steroids or currently treated with steroids between the ages of 4 and 18 years
Key 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
Date of first enrolment	01/01/2006
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Dept of Rheumatology

Belfast
BT9 7JB
United Kingdom

Sponsor information

Greenpark Healthcare Trust (UK)
Hospital/treatment centre

Musgrave Park Hospital
Stockmans lane
Belfast
BT97JB
Northern Ireland
United Kingdom

Phone	+44 (0)2890902880
Email	katrina.hughes@greenpark.n-i.nhs.uk
"ROR"	https://ror.org/02tdmfk69

Funders

Funder type

Charity

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator