Condition category
Musculoskeletal Diseases
Date applied
22/08/2005
Date assigned
15/09/2005
Last edited
24/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
Stockman’s 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

Publication citations

Additional files

Editorial Notes

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