Risedronate treatment for Children with severe Osteogenesis Imperfecta
| ISRCTN | ISRCTN76376467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76376467 |
| Secondary identifying numbers | B0696 |
- Submission date
- 04/02/2002
- Registration date
- 04/02/2002
- Last edited
- 03/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Professor Nick Bishop
Scientific
Scientific
Institute of Child Health
University of Sheffield
Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 271 7677 |
|---|---|
| n.j.bishop@sheffield.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Bisphosphonate administration in children with severe osteogenesis imperfecta: A prospective randomised double blind controlled study of risedronate |
| Study acronym | RICO trial |
| Study objectives | Children aged between four and seventeen who have osteogenesis imperfecta, which is a form of osteoporosis which causes multiple fractures, deformity and stunted growth, are to be offered Risedronate in a clinical trial aimed at increasing bone density. |
| Ethics approval(s) | South Sheffield Research Ethics Committee. Date of approval: 06/12/1999 (ref: SS 98/183) |
| Health condition(s) or problem(s) studied | Osteogenesis imperfecta |
| Intervention | Patients will be randomised to either low (0.2 mg/kg/week), medium (1 mg/kg/week) or high (2 mg/kg/week) dose of the bisphosphonate risedronate. Treatment will continue for 3 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bisphosphonate risedronate |
| Primary outcome measure | Added as of 10/04/2008: Number of incident non-vertebral fractures in each group at 2 years. |
| Secondary outcome measures | Added as of 10/04/2008: The following were assessed at 2 years: 1. Total body and lumbar spine bone area 2. Bone mineral content 3. Areal bone mineral density and volumetric bone mineral density |
| Overall study start date | 31/07/2001 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | Added as of 10/04/2008: Planned recruitment: 60; Actual recruitment: 53 |
| Key inclusion criteria | Inclusion criteria amended as of 15/04/2008: 1. Children with osteogenesis imperfecta 2. Aged between 3 and 17 ("Aged between 4 and 17" at ethics approval. We subsequently had an approved amendment to reduce the lower age limit to 3 years; this applied to only one child) 3. Both male and female Inclusion criterion provided at time of registration: Children with osteogenesis imperfecta |
| Key exclusion criteria | Added as of 10/04/2008: 1. Have a history of cancer 2. Have untreated rickets within one year prior to enrollment 3. 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 4. Have markedly abnormal pretreatment laboratory findings, except if in the opinion of the investigator, it would not prevent the patient from completing the study 5. Have a history of using anabolic steroids/estrogens/androgens within one year of enrollment 6. Have a history of using any of the following medications within 6 month of starting study drug for more than one month: calcitonin, vitamin D supplements >1000 IU per day, and calcitriol >1.5 mg/week 7. Have a history of using any bisphosphonate (except for more than a single dose of risedronate) and/or fluoride (>10 mg per day). Have a documented history of an abnormal or allergic reaction to bisphosphonates 8. Pregnancy or sexually active subjects unwilling to take appropriate contraceptive measures 9. Any limb-lengthening procedure within 6 of enrollment 10. Participation in another clinical trial, involving active intervention within 30 days prior to enrollment 11. Serum creatinine >150 µmol/L |
| Date of first enrolment | 31/07/2001 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Child Health
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (ARC) (UK)
No information available
Alliance for Better Bone Health (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2010 | Yes | No |
