Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT00822029|
Recruitment Status : Terminated (only 2 patients inclued and Study Principal Investigator has left the hospital)
First Posted : January 14, 2009
Last Update Posted : March 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Cerebral Palsy||Drug: FOSAMAX Other: PLACEBO||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822029
|Chirurgie Infantile - Hôpital ARCHET|
|Nice, France, 06003|
|Principal Investigator:||Jacques GRIFFET, PhD||CHU de Nice|