Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy|
- To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry. [ Time Frame: one year ] [ Designated as safety issue: No ]
- To estimate the improvement of the biological and clinical consequences (bone pains and fractures) of osteoporosis. To estimate the improvement of the quality of life To estimate the tolerance of oral bisphosphonates. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
FOSAMAX (oral bisphosphonate)
patient receiving one tablet (oral use) 70 mg Fosamax by week
Placebo Comparator: 2
patient receiving one tablet (oral use) placebo by week
In non walking children with cerebral palsy, osteoporosis is responsible for bone pains and iterative fractures. Classical treatments include physiotherapy, assisted verticalisation by orthesis and correct feeding with vitamin D and calcium supplementation. Yet this isn't always sufficient and isn't always possible.
Bisphosphonates, which have been used for years in the treatment of post-menopausic osteoporosis or of osteogenesis imperfecta in children, can turn out to be very useful for non-walking children with cerebral palsy.
Studies have been published since 1994 in this indication with encouraging results. Cyclic intravenous administration of bisphosphonates every 3 months showed an objective increase in bone density and a decrease in pains and fractures after one year of treatment. Cyclic intravenous administration nevertheless requires the use of an implanted chamber and iterative hospitalizations. Oral administration should allow to treat these children, who already have many treatments, in a simpler way.
The study will concern 40 non-walking children with cerebral palsy aged over 10 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822029
|Chirurgie Infantile - Hôpital ARCHET|
|Nice, France, 06003|
|Principal Investigator:||Jacques GRIFFET, PhD||CHU de Nice|