Steroid induced osteopaenia: prophylaxis and treatment in paediatric rheumatic diseases
| ISRCTN | ISRCTN66814619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66814619 |
| Protocol serial number | 15936 |
| Sponsor | Greenpark Healthcare Trust (UK) |
| Funder | Arthritis Research Campaign (ARC) (UK) (ref: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
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 |
|---|---|
| m.rooney@qub.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | One alpha hydroxycholecalciferol, Risedronate |
| Primary outcome measure(s) |
An improvement of 0.5 SDS in bone mineral density (BMD) in the treated group compared to the control |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| 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
- United Kingdom
- Northern Ireland
Study participating centre
Dept of Rheumatology
Belfast
BT9 7JB
United Kingdom
BT9 7JB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator
