Osteogenesis imperfecta Musculoskeletal Diseases Osteogenesis imperfecta
Conditions
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.
Sponsors
Arthritis Research Campaign (ARC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 10/04/2008: Number of incident non-vertebral fractures in each group at 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed