A Phase 3 interventional study of FOSAMAX and PLACEBO in Osteoporosis and Cerebral Palsy, sponsored by Department of Clinical Research and Innovation. Terminated at 1 site in France. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2012-03-26.
Sponsored by Department of Clinical Research and Innovation · Phase 3, Interventional, and Treatment
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).
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 2 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Department of Clinical Research and Innovation is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
FOSAMAX (oral bisphosphonate)
Drug: FOSAMAX
PLACEBO
Other: PLACEBO
patient receiving one tablet (oral use) 70 mg Fosamax by week
patient receiving one tablet (oral use) placebo by week
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.
Time frame: one year
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
This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Department of Clinical Research and Innovation