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06 September 2008
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| [ Print-friendly version ] |
| Risedronate treatment for Children with severe Osteogenesis Imperfecta |
| ISRCTN | ISRCTN76376467 |
| ClinicalTrials.gov identifier | |
| Public title | Risedronate treatment for Children with severe Osteogenesis Imperfecta |
| Scientific title | Bisphosphonate administration in children with severe osteogenesis imperfecta: A prospective randomised double blind controlled study of risedronate |
| Acronym | RICO trial |
| Serial number at source | B0696 |
| Study hypothesis | 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 | South Sheffield Research Ethics Committee. Date of approval: 06/12/1999 (ref: SS 98/183) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Osteogenesis imperfecta |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 31/07/2001 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Added as of 10/04/2008: Planned recruitment: 60; Actual recruitment: 53 |
| Interventions | 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. |
| Primary outcome measure(s) |
Added as of 10/04/2008:
Number of incident non-vertebral fractures in each group at 2 years. |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. Arthritis Research Campaign (ARC) (UK)
2. Alliance for Better Bone Health (UK) |
| Trial website | |
| Publications | |
| Contact name | Professor Nick Bishop |
| Address |
Institute of Child Health
University of Sheffield Children's Hospital Western Bank |
| City/town | Sheffield |
| Zip/Postcode | S10 2TH |
| Country | United Kingdom |
| Tel | +44 (0)114 271 7677 |
| Fax | +44 (0)114 275 5364 |
| n.j.bishop@sheffield.ac.uk | |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Address |
Copeman House
St Mary's Court St Mary's Gate Chesterfield |
| City/town | Derbyshire |
| Zip/Postcode | S41 7TD |
| Country | United Kingdom |
| info@arc.org.uk | |
| Sponsor website: | http://www.arc.org.uk |
| Date applied | 04/02/2002 |
| Last edited | 15/04/2008 |
| Date ISRCTN assigned | 04/02/2002 |
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